{"id":8408,"date":"2021-03-09T14:08:59","date_gmt":"2021-03-09T19:08:59","guid":{"rendered":"http:\/\/localhost:10028\/uncategorized\/penumbra-jet-7-catheters-lawyers\/"},"modified":"2021-03-09T14:08:59","modified_gmt":"2021-03-09T19:08:59","slug":"penumbra-jet-7-catheters-%e5%bc%81%e8%ad%b7%e5%a3%ab","status":"publish","type":"post","link":"https:\/\/napolilaw.lemonadestand.org\/ja\/article\/penumbra-jet-7-catheters-%e5%bc%81%e8%ad%b7%e5%a3%ab\/","title":{"rendered":"\u30da\u30ca\u30f3\u30d6\u30e9 JET 7 \u30ab\u30c6\u30fc\u30c6\u30eb\u5f01\u8b77\u58eb"},"content":{"rendered":"<p>\u901a\u5e38\u3001\u8133\u5352\u4e2d\u306f\u3001\u6700\u3082\u81f4\u547d\u7684\u307e\u305f\u306f\u6700\u3082\u81f4\u547d\u7684\u3067\u306a\u3044\u5fc3\u8840\u7ba1\u30a8\u30d4\u30bd\u30fc\u30c9\u3067\u3059\u3002\u9ad8\u5ea6\u306a\u30ab\u30c6\u30fc\u30c6\u30eb\u3084\u305d\u306e\u4ed6\u306e\u533b\u7642\u6a5f\u5668\u306e\u51fa\u73fe\u306b\u3088\u308a\u30011990 \u5e74\u4ee3\u4ee5\u964d\u3001\u8133\u5352\u4e2d\u306e\u751f\u5b58\u7387\u306f\u5927\u5e45\u306b\u5411\u4e0a\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u305f\u3060\u3057\u3001\u3053\u308c\u3089\u306e\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u591a\u304f\u306e\u5834\u5408\u3001\u5229\u76ca\u3088\u308a\u3082\u5bb3\u3092\u53ca\u307c\u3059\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u591a\u304f\u306e\u5834\u5408\u3001\u6025\u3044\u3067 <a href=\"\/ja\/%e7%b7%b4%e7%bf%92%e5%a0%b4\/%e8%a3%bd%e8%96%ac%e8%a8%b4%e8%a8%9f\/%e3%83%98%e3%83%ab%e3%83%8b%e3%82%a2%e3%83%a1%e3%83%83%e3%82%b7%e3%83%a5%e8%a8%b4%e8%a8%9f\/\">\u3088\u308a\u826f\u3044\u30cd\u30ba\u30df\u6355\u308a\u3092\u4f5c\u308b<\/a>\u3001\u30c7\u30d0\u30a4\u30b9\u30e1\u30fc\u30ab\u30fc\u306f\u5371\u967a\u306a\u8fd1\u9053\u3092\u3057\u3001\u4eba\u3005\u306f\u602a\u6211\u3092\u3057\u307e\u3059\u3002<\/p>\n<p>\u30a2\u30b0\u30ec\u30c3\u30b7\u30d6 <a href=\"\/ja\/%e7%b7%b4%e7%bf%92%e5%a0%b4\/%e8%a3%bd%e8%96%ac%e8%a8%b4%e8%a8%9f\/%e3%82%b8%e3%82%a7%e3%83%83%e3%83%88-7-%e3%82%ab%e3%83%86%e3%83%bc%e3%83%86%e3%83%ab\/\">\u30da\u30ca\u30f3\u30d6\u30e9 JET 7<\/a> \u30ab\u30c6\u30fc\u30c6\u30eb\u5f01\u8b77\u58eb <a href=\"\/ja\/our-attorneys\/\">\u30ca\u30dd\u30ea\u30fb\u30b7\u30e5\u30b3\u30eb\u30cb\u30af<\/a> \u533b\u7642\u6a5f\u5668\u306b\u3088\u308b\u88ab\u5bb3\u8005\u3092\u8868\u3057\u307e\u3059\u3002<\/p>\n<p>\u307b\u3068\u3093\u3069\u306e\u533b\u7642\u6a5f\u5668\u4f1a\u793e\u306f\u5229\u76ca\u3060\u3051\u3092\u6c17\u306b\u3057\u307e\u3059\u3002\u79c1\u305f\u3061\u306f\u3042\u306a\u305f\u306e\u5065\u5eb7\u3068\u5b89\u5168\u3060\u3051\u3092\u6c17\u306b\u3057\u307e\u3059\u3002<\/p>\n<p>\u3053\u308c\u3089\u306e\u4f01\u696d\u306b\u88dc\u511f\u306e\u652f\u6255\u3044\u3092\u5f37\u5236\u3059\u308b\u3053\u3068\u304c\u3001\u3053\u306e\u76ee\u6a19\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306e\u6700\u826f\u306e\u65b9\u6cd5\u3067\u3059\u3002<\/p>\n<p>\u3053\u308c\u3089\u306e\u4f01\u696d\u306f\u5229\u76ca\u3092\u91cd\u8996\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u5229\u76ca\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3053\u3068\u304c\u4eba\u3005\u306e\u5b89\u5168\u3092\u78ba\u4fdd\u3059\u308b\u552f\u4e00\u306e\u52b9\u679c\u7684\u306a\u65b9\u6cd5\u3067\u3059\u3002<\/p>\n<h2>Penumbra JET 7 \u30ab\u30c6\u30fc\u30c6\u30eb\u3068 FDA \u627f\u8a8d<\/h2>\n<p>\u30dd\u30f3\u30d7\u3068\u30c1\u30e5\u30fc\u30d6\u3068\u3068\u3082\u306b\u3001\u3053\u306e\u30ab\u30c6\u30fc\u30c6\u30eb\u306f\u3001Penumbra \u306e\u6a5f\u68b0\u7684\u8840\u6813\u9664\u53bb\u30bb\u30c3\u30c8\u306e\u4e00\u90e8\u3067\u3059\u3002<\/p>\n<p>\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u771f\u7a7a\u30dd\u30f3\u30d7\u3092\u4f7f\u7528\u3057\u3066\u8840\u6813\u3092\u53d6\u308a\u9664\u304d\u307e\u3059\u3002<\/p>\n<p>JET 7 \u306f\u307e\u305f\u3001\u91cd\u5ea6\u306e\u8840\u6813\u3092\u691c\u51fa\u3059\u308b\u305f\u3081\u306b\u4f4e\u30ec\u30d9\u30eb\u306e\u653e\u5c04\u7dda\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002 Penumbra \u306f\u3001\u3053\u306e\u51e6\u7f6e\u306b\u3088\u308a\u3001\u308f\u305a\u304b 8 \u6642\u9593\u3067\u8133\u5352\u4e2d\u60a3\u8005\u304b\u3089\u8840\u6813\u3092\u9664\u53bb\u3067\u304d\u308b\u3068\u4e3b\u5f35\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u6a5f\u68b0\u7684\u8840\u6813\u9664\u53bb\u8853\u306f\u3001\u6297\u51dd\u56fa\u85ac\u306b\u53cd\u5fdc\u3057\u306a\u3044\u8133\u5352\u4e2d\u60a3\u8005\u5411\u3051\u306b\u8a2d\u8a08\u3055\u308c\u305f\u3001\u8907\u96d1\u3067\u7269\u8b70\u3092\u91b8\u3059\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002<\/p>\n<p>\u3053\u308c\u3089\u306e\u85ac\u306f\u3001\u7279\u5b9a\u306e\u5927\u304d\u306a\u8840\u6813\u3092\u51e6\u7406\u3067\u304d\u307e\u305b\u3093\u3002\u30d7\u30e9\u30c0\u30af\u30b5\u306e\u3088\u3046\u306a\u5f37\u529b\u306a\u8840\u6db2\u5e0c\u91c8\u5264\u306e\u526f\u4f5c\u7528\u306b\u8010\u3048\u3089\u308c\u306a\u3044\u60a3\u8005\u3082\u3044\u307e\u3059\u3002<\/p>\n<p>JET 7 \u306e\u627f\u8a8d\u306f\u3001\u305d\u306e\u904b\u7528\u3068\u540c\u69d8\u306b\u7269\u8b70\u3092\u304b\u3082\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u306f\u3001\u30bb\u30af\u30b7\u30e7\u30f3 510(k) \u306e\u5b9f\u8cea\u7684\u7b49\u4fa1\u6761\u9805\u306e\u4e0b\u3067\u3001\u3053\u306e\u30c7\u30d0\u30a4\u30b9\u3092\u8fc5\u901f\u306b\u8ffd\u8de1\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u30c7\u30d0\u30a4\u30b9\u304c\u3059\u3067\u306b\u5e02\u5834\u306b\u51fa\u56de\u3063\u3066\u3044\u308b\u30c7\u30d0\u30a4\u30b9\u3068\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u3067\u3042\u308b\u5834\u5408\u3001FDA \u306f\u65b0\u3057\u3044\u30ac\u30b8\u30a7\u30c3\u30c8\u304c\u5b89\u5168\u3067\u3042\u308b\u3068\u63a8\u5b9a\u3057\u307e\u3059\u3002<\/p>\n<p>\u898f\u5247\u306f SE \u88fd\u54c1\u3092\u660e\u78ba\u306b\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u3053\u308c\u3089\u306e\u898f\u5247\u306e\u9069\u7528\u306f\u4e3b\u89b3\u7684\u306a\u3082\u306e\u3067\u3059\u3002<\/p>\n<p>\u305d\u3057\u3066\u3001\u57fa\u672c\u7684\u306b\u898b\u843d\u3068\u3057\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<p>\u4f55\u304c\u540c\u7b49\u3067\u4f55\u304c\u540c\u7b49\u3067\u306a\u3044\u304b\u306f\u3001\u5b98\u50da\u304c\u4e00\u65b9\u7684\u306b\u6c7a\u3081\u308b\u3002\u3055\u3089\u306b\u3001\u65b0\u88fd\u54c1\u3092\u72ec\u7279\u306a\u3082\u306e\u306b\u3059\u308b\u6a5f\u80fd\u306f\u3001\u3057\u3070\u3057\u3070\u305d\u308c\u3092\u5371\u967a\u306a\u3082\u306e\u306b\u3057\u307e\u3059\u3002\u4eca\u56de\u306e\u4ef6\u306f\u305d\u3093\u306a\u72b6\u6cc1\u3067\u3057\u305f\u3002<\/p>\n<h2>\u5408\u4f75\u75c7\u3068\u526f\u4f5c\u7528<\/h2>\n<p>\u4e00\u822c\u306b\u3001\u6a5f\u68b0\u306b\u53ef\u52d5\u90e8\u54c1\u304c\u591a\u3044\u307b\u3069\u3001\u554f\u984c\u304c\u767a\u751f\u3057\u307e\u3059\u3002 JET 7 \u306e\u9ad8\u5ea6\u306a\u6a5f\u80fd\u306b\u3088\u308a\u3001\u6b21\u306e\u3088\u3046\u306a\u554f\u984c\u304c\u767a\u751f\u3057\u307e\u3057\u305f\u3002<\/p>\n<ul>\n<li>\u9020\u5f71\u5264\u306b\u3088\u308b\u30a2\u30ca\u30d5\u30a3\u30e9\u30ad\u30b7\u30fc\u53cd\u5fdc\u3001<\/li>\n<li>\u6025\u6027\u9589\u585e\u304a\u3088\u3073\u7a7a\u6c17\u585e\u6813\u75c7\uff08\u9589\u585e\u3057\u305f\u52d5\u8108\uff09\u3001<\/li>\n<li>\u9060\u4f4d\u585e\u6813\u8853\uff08\u52d5\u8108\u5185\u306e\u7a7a\u6c17\uff09\u3001<\/li>\n<li>\u585e\u6813\u75c7\uff08\u52d5\u8108\u306e\u8102\u80aa\u6c88\u7740\uff09\u3001<\/li>\n<li>\u4eee\u6027\u52d5\u8108\u7624\uff08\u52d5\u8108\u306e\u6f0f\u308c\uff09\u3001<\/li>\n<li>\u91cd\u5ea6\u306e\u51fa\u8840\u3084\u3042\u3056\u3001<\/li>\n<li>\u814e\u81d3\u306e\u640d\u50b7\u3001<\/li>\n<li>\u8840\u7ba1\u7a7f\u5b54\u3001\u304a\u3088\u3073<\/li>\n<li>\u653e\u5c04\u7dda\u88ab\u3070\u304f\u3002<\/li>\n<\/ul>\n<p>\u3055\u3089\u306b\u3001\u53ef\u52d5\u90e8\u54c1\u306e\u6570\u304c\u591a\u3059\u304e\u308b\u3068\u3001\u88fd\u9020\u4e0a\u306e\u6b20\u9665\u306e\u30ea\u30b9\u30af\u304c\u9ad8\u307e\u308a\u307e\u3059\u3002\u3059\u3079\u3066\u306e\u90e8\u54c1\u304c\u9069\u5207\u306b\u52a0\u5de5\u3055\u308c\u3066\u3044\u306a\u3044\u3068\u3001\u9069\u5207\u306b\u9023\u643a\u3057\u307e\u305b\u3093\u3002<\/p>\n<p>\u3057\u305f\u304c\u3063\u3066\u3001JET 7 \u30ab\u30c6\u30fc\u30c6\u30eb\u3067\u8ca0\u50b7\u3057\u305f\u5834\u5408\u3001\u554f\u984c\u306f\u8a2d\u8a08\u4e0a\u306e\u6b20\u9665\u307e\u305f\u306f\u88fd\u9020\u4e0a\u306e\u6b20\u9665\u3067\u3042\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u79c1\u305f\u3061\u306e\u30c1\u30fc\u30e0\u306f\u3001\u884c\u52d5\u3092\u8d77\u3053\u3059\u524d\u306b\u3042\u306a\u305f\u306e\u30b1\u30fc\u30b9\u3092\u614e\u91cd\u306b\u8a55\u4fa1\u3057\u307e\u3059.<\/p>\n<h2>\u640d\u5bb3\u8ce0\u511f\u8acb\u6c42<\/h2>\n<p>\u8cac\u4efb\u306b\u95a2\u3057\u3066\u306f\u3001\u8a2d\u8a08\u4e0a\u306e\u6b20\u9665\u3068\u88fd\u9020\u4e0a\u306e\u6b20\u9665\u306e\u9593\u306b\u307b\u3068\u3093\u3069\u9055\u3044\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u88fd\u54c1\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u4e21\u65b9\u306e\u554f\u984c\u306b\u5bfe\u3057\u3066\u53b3\u5bc6\u306b\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u8a3c\u660e\u306b\u95a2\u3057\u3066\u306f\u3001\u5927\u304d\u306a\u9055\u3044\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>Napoli Shkolnik 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7 \u30ab\u30c6\u30fc\u30c6\u30eb\u306e\u3088\u3046\u306a\u9ad8\u5ea6\u306a\u533b\u7642\u6a5f\u5668\u306b\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u5b8c\u5168\u306b\u958b\u793a\u3057\u3066\u3044\u306a\u3044\u6df1\u523b\u306a\u30ea\u30b9\u30af\u304c\u4f34\u3046\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u85ac\u4e8b\u8a34\u8a1f\u7d4c\u9a13\u8c4a\u5bcc\u306a\u5f01\u8b77\u58eb\u306b\u3088\u308b\u7121\u6599\u76f8\u8ac7\u306f\u3001 <a href=\"\/ja\/%e3%81%8a%e5%95%8f%e3%81%84%e5%90%88%e3%82%8f%e3%81%9b\/\">\u30ca\u30dd\u30ea\u30fb\u30b7\u30e5\u30b3\u30eb\u30cb\u30af\u306b\u9023\u7d61\u3059\u308b 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