Panels › Cardiovascular › Product code DYB · Class 2
Introducer, Catheter
Regulation 870.1340
19510(k)s in 12 months (707 all time)
27recalls in 12 months (389 all time)
337recalls that name a 510(k)
Top companies in DYB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 20 | 67 |
| Terumo Medical Corp. | 27 | 29 |
| Merit Medical Systems | 19 | 35 |
| Oscor, Inc. | 13 | 37 |
| ARROW INTERNATIONAL, LLC | 0 | 37 |
| Abiomed, Inc. | 6 | 28 |
| Thomas Medical Products, Inc. | 17 | 15 |
| St Jude Medical | 26 | 3 |
| Cordis Corp. | 22 | 3 |
| Boston Scientific | 16 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 1992 | K920998 | GORE TUNNELER, MODIFICATION W. L. Gore & Associates, Inc. | DYB |
| Jun 3, 1992 | K920779 | FAST-CATH HEMOSTASIS INTRODUCER Daig Corp. | DYB |
| Jun 3, 1992 | K915625 | INTRODUCER CATHETER Interventional Therapeutics Corp. | DYB |
| Apr 16, 1992 | K920327 | DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER Daig Corp. | DYB |
| Mar 18, 1992 | K920251 | USCI HEMAQUET XT INTRODUCER C.R. Bard, Inc. | DYB |
| Feb 27, 1992 | K915421 | GUIDEWIRE INTRODUCER SET B. Braun of America, Inc. | DYB |
| Feb 21, 1992 | K915553 | USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING C.R. Bard, Inc. | DYB |
| Jan 27, 1992 | K915167 | GESCO PER-Q-CATH CATHETER INTRODUCER Gesco Intl., Inc. | DYB |
| Dec 20, 1991 | K914330 | SOS BLOODLESS NEEDLE E-Z-Em, Inc. | DYB |
| Nov 29, 1991 | K911883 | DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER Diag Corp. | DYB |
| Nov 22, 1991 | K914352 | CORDIS OBTURATOR Cordis Corp. | DYB |
| Nov 8, 1991 | K914046 | THE BIG EASY Y-ADAPTER Microvena Corp. | DYB |
| Oct 28, 1991 | K914090 | DAIG FAST CATH(TM) INTRODUCER, MODIFICATION Daig Corp. | DYB |
| Oct 16, 1991 | K913801 | CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL Cordis Corp. | DYB |
| Sep 11, 1991 | K912961 | MORSE VASCULAR INTRODUCER SET North American Instrument Corp. | DYB |
| Jul 19, 1991 | K911794 | CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE Cordis Corp. | DYB |
| Jul 12, 1991 | K911678 | ROTATING HEMOSTATIC VALVE Devices For Vascular Intervention, Inc. | DYB |
| Jun 18, 1991 | K911236 | MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS Medtronic Vascular | DYB |
| Jun 3, 1991 | K910933 | OLYMPUS ANGIOSCOPY IRRIGATION SHEATH Olympus Corp. | DYB |
| May 16, 1991 | K910688 | CORDIS PEEL-AWAY INSERTION TOOL Cordis Corp. | DYB |
| May 7, 1991 | K910861 | PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK Daig Corp. | DYB |
| Apr 1, 1991 | K904475 | ENTREE SHEATH INTRODUCER SYSTEM Cordis Corp. | DYB |
| Jan 3, 1991 | K903463 | IVT INTRODUCER SHEATH Intensive Technology, Inc. | DYB |
| Oct 31, 1990 | K903410 | BIO-MEDICUS CANNULA INTRODUCER Bio Medicus, Inc. | DYB |
| Oct 22, 1990 | K903530 | PERCUTANEOUS INTRODUCERS Davol, Inc. | DYB |
| Oct 16, 1990 | K903840 | GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY Intec Medical, Inc. | DYB |
| Oct 16, 1990 | K902932 | DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL Datascope Corp. | DYB |
| Sep 26, 1990 | K903906 | PERCUTANEOUS CATHETER INTRODUCER KIT Intec Medical, Inc. | DYB |
| Sep 26, 1990 | K902275 | PERCUTANEOUS INTRODUCER SET Thomas Medical Products, Inc. | DYB |
| Aug 24, 1990 | K902477 | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET Medical Engineering and Development Institute | DYB |
| Aug 23, 1990 | K903442 | ARIES TAPERSEAL(TM) SHEATH Aries Medical, Inc. | DYB |
| Aug 23, 1990 | K900658 | INTRODUCER, PERCUTANEOUS Novoste Puerto Rico, Inc. | DYB |
| Aug 23, 1990 | K900515 | MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S) Medtronic Vascular | DYB |
| Aug 8, 1990 | K900756 | ITC INTRODUCER CATHETER Interventional Therapeutics Corp. | DYB |
| Jul 31, 1990 | K902251 | SUBCLAVIAN INTRODUCER SET Infusaid Corp. | DYB |
| Jun 26, 1990 | K901391 | DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER Datascope Corp. | DYB |
| May 22, 1990 | K901452 | USCI(R) ACCESS(TM) INTRODUCER SET C.R. Bard, Inc. | DYB |
| Apr 30, 1990 | K895580 | Y-ADAPTER W/THOUY BORST Angeion Corp. | DYB |
| Mar 16, 1990 | K897041 | HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS C.R. Bard, Inc. | DYB |
| Feb 26, 1990 | K895044 | DUAL GUIDE INTRODUCER CATHETER Cook, Inc. | DYB |
| Dec 5, 1989 | K891121 | MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM Boston Scientific Corp | DYB |
| Nov 30, 1989 | K894446 | ANGEION HEMOSTASIS VALVE INTRODUCER Angeion Corp. | DYB |
| Nov 14, 1989 | K895214 | HEMOSTASIS VALVE Applied Vascular Devices, Inc. | DYB |
| Oct 2, 1989 | K894445 | MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE Mallinckroot, Inc. | DYB |
| Sep 28, 1989 | K894157 | OBTURATOR Argon Medical Corp. | DYB |
| Sep 26, 1989 | K894343 | DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO Daig Corp. | DYB |
| Sep 18, 1989 | K890766 | CATHETER INTRODUCER SHEATH Applied Vascular Devices, Inc. | DYB |
| Sep 6, 1989 | K894431 | MODIFIED LABELING TO PERMANENT LEAD INTRODUCER Daig Corp. | DYB |
| Aug 9, 1989 | K894430 | MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY Daig Corp. | DYB |
| Aug 9, 1989 | K885179 | INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD Baxter Healthcare Corp | DYB |
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