510(k) Premarket Notification | 合法醫療器材資訊網
Results1-10of26—ProductCode:LITApplicant:CORDISCORP....16.powerflexpropercutaneoustransluminalangioplastycatheter17,CORDISCORP.K11279718,05/04/2012.cordisamiia.014ptaballooncatheter19,CORDISCORP.K05064520,04/01/2005.cord
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
Learn more...[1]
References Learn more... (www.fda.gov)
"CORDIS" AMIIA.014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER "CORDIS" AMIIA.014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER 重彈輕彈 皮膚膜 高雄 慕 樂 貼 布 台灣明尼蘇達礦業製造股份有限公司統編 “史耐輝”舒軟膠布 (未滅菌) Johnson & Johnson job 嬌生 Trainee 嬌 生 產業
特材收載品項 | 合法醫療器材資訊網
SQL | 合法醫療器材資訊網
CBB0114508MT, XXL BALLOON DILATATION CATHETER, 14-508:14-559, EA ... AMIIA.014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY(PTA) ... CBB01424NWCD, "CORDIS"AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ... Read More
"考迪斯"愛美亞擴張導管"CORDIS" AMIIA.014 PERCUTANEOUS ... | 合法醫療器材資訊網
"考迪斯"愛美亞擴張導管"CORDIS" AMIIA.014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER / 詳如中文仿單核定本/ 藥要看 ... Read More
510(k) Premarket Notification | 合法醫療器材資訊網
Results 1 - 10 of 26 — ProductCode: LIT Applicant: CORDIS CORP. ... 16. powerflex pro percutaneous transluminal angioplasty catheter17, CORDIS CORP. K11279718, 05/04/2012. cordis amiia .014 pta balloon catheter19, CORDIS CORP. K05064520, 04/01/2005. cord Read More
510(k) Premarket Notification | 合法醫療器材資訊網
ProductCode: LIT Applicant: CORDIS CORP. ... powerflex pro percutaneous transluminal angioplasty catheter17, CORDIS ... cordis amiia .014 pta balloon catheter19, CORDIS CORP. ... cordis m3 pta dilatation catheter21, CORDIS CORP. Read More
510(k) | 合法醫療器材資訊網
Cordis AMIIA .014" PTA Balloon Catheter. Attachment B: ... Cordis AMIIATM Percutaneous Transluminal Angioplasty (PTA) Catheter. Classification Name ... Read More
Cordis Endovascular Catalog | 合法醫療器材資訊網
POWERFLEX® Extreme PTA Dilatation Catheter 48. • OPTA® Pro ... CORDIS® .014” PTA Balloons 56 ... is indicated for Percutaneous Transluminal Angioplasty. Read More
Medisurf's Categories | 合法醫療器材資訊網
There are no further sub-categories for 'Percutaneous catheter.' ... Brand : C.R.BARD, INC. / Model : CONQUEST PTA BALLOON DILATATION CATHETER / / FDA Class 2 ... CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER ... Model : CORDIS AMIIA .014 PTA BA Read More
相關資訊整理
【"考迪斯"愛美亞擴張導管】許可證字號:衛署醫器輸字第014213號
器材品名:"考迪斯"愛美亞擴張導管許可證字號:衛署醫器輸字第014213號註銷狀態:已註銷註銷日期:2012/11/27註銷理由:許可證已...