Panels › Cardiovascular › Product code DQY · Class 2
Catheter, Percutaneous
Regulation 870.1250
13510(k)s in 12 months (896 all time)
2recalls in 12 months (620 all time)
583recalls that name a 510(k)
Top companies in DQY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 31 | 198 |
| Medtronic | 15 | 148 |
| Boston Scientific | 30 | 59 |
| ARROW INTERNATIONAL, LLC | 0 | 41 |
| Stryker Neurovascular | 6 | 30 |
| Cook Incorporated | 22 | 13 |
| Vascular Solutions, Inc. | 27 | 6 |
| Codman & Shurtleff, Inc. | 8 | 24 |
| Bard Peripheral Vascular, Inc. | 5 | 23 |
| Cordis Corp. | 22 | 4 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 24, 2000 | K000598 | 5F GUIDING CATHETER Guidant Corp. | DQY |
| Feb 25, 2000 | K994229 | VERIPATH PERIPHERAL GUIDING CATHETER Advanced Cardiovascular Systems, Inc. | DQY |
| Nov 16, 1999 | K991059 | SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 Spectranetics Corp. | DQY |
| Oct 28, 1999 | K991601 | DUAL LUMEN CATHETER, MODEL DL-35-90 Endologix, Inc. | DQY |
| Oct 12, 1999 | K992673 | VISTA BRITE TIP CATHETERS Cordis Corp. | DQY |
| Sep 29, 1999 | K992622 | INTRAMAX ITI GUIDE CATHETER Intratherapeutics, Inc. | DQY |
| Jul 30, 1999 | K984482 | AVE GL-1 GUIDING CATHETER Arterial Vascular Engineering Massachusetts, Inc. | DQY |
| Jun 22, 1999 | K974683 | NAVIPORT DEFLECTABLE TIP GUIDING CATHETER Cardima, Inc. | DQY |
| Apr 7, 1999 | K981191 | ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 Intratherapeutics, Inc. | DQY |
| Apr 2, 1999 | K990726 | ENVY GUIDING CATHETER Cook, Inc. | DQY |
| Mar 22, 1999 | K990707 | MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS Medtronics Interventional Vascular | DQY |
| Jan 27, 1999 | K981359 | GT LEGGIERO Terumo Medical Corp. | DQY |
| Jan 27, 1999 | K972065 | AURORA Neurovena Corp. | DQY |
| Nov 20, 1998 | K980278 | URESIL VASCU-FLO INFUSION CATHETER Uresil Corp. | DQY |
| Sep 4, 1998 | K982883 | MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER Medtronics Interventional Vascular | DQY |
| Aug 18, 1998 | K982770 | 6F ENVOY GUIDING CATHETER Cordis Corp. | DQY |
| Aug 18, 1998 | K982632 | ENVOY AND VISTA BRITE TIP Cordis Corp. | DQY |
| Aug 11, 1998 | K980453 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS Boston Scientific Scimed, Inc. | DQY |
| Aug 7, 1998 | K981198 | MEDTRONIC ZUMA GUIDING CATHETER Medtronics Interventional Vascular | DQY |
| Jun 26, 1998 | K973298 | CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER Cardima, Inc. | DQY |
| Jun 10, 1998 | K970668 | THE AMPLANTZ GOOSE NECK MICROSNARE Microvena Corp. | DQY |
| May 13, 1998 | K981413 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS Boston Scientific Scimed, Inc. | DQY |
| Feb 19, 1998 | K974684 | SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER Scimed Life Systems, Inc. | DQY |
| Nov 24, 1997 | K973371 | CERTODYN RAECG UNIVERSAL ADAPTER B.Braun Medical, Inc. | DQY |
| Oct 21, 1997 | K972978 | VISTA BRITE TIP GUIDING CATHETERS Cordis Corp. | DQY |
| Sep 26, 1997 | K972484 | ACS VIKING GUIDING CATHETER Guidant Corp. | DQY |
| Aug 1, 1997 | K970401 | MEDI-DYNE GUIDING CATHETER Medi-Dyne, Inc. | DQY |
| Jul 23, 1997 | K965247 | ENVOY GUIDING CATHETER Cordis Neurovascular, Inc. | DQY |
| Jul 14, 1997 | K971572 | VISTA BRITE TIP CATHETERS Cordis Corp. | DQY |
| Jun 3, 1997 | K970823 | SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER Scimed Life Systems, Inc. | DQY |
| May 7, 1997 | K963962 | VISTA BRITE TIP CATHETERS Cordis Corp. | DQY |
| Mar 11, 1997 | K965211 | VISTA BRITE TIP CATHETERS Cordis Corp. | DQY |
| Feb 12, 1997 | K962717 | 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING Biocompatibles Cardiovascular, Inc. | DQY |
| Jan 13, 1997 | K963663 | 11F GUIDING CATHETER Boston Scientific /International Technologies | DQY |
| Oct 17, 1996 | K962830 | VISTA BRITE TIP CATHETERS Cordis Corp. | DQY |
| Aug 8, 1996 | K962362 | CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS Cordis Corp. | DQY |
| May 15, 1996 | K961280 | SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F Scimed Life Systems, Inc. | DQY |
| Jan 22, 1996 | K955651 | MEDTRONIC SHERPA GUIDING CATHETER Medtronics Interventional Vascular | DQY |
| Jan 16, 1996 | K953265 | SCIMED ANGIOGRAPHIC KITS Scimed Life Systems, Inc. | DQY |
| Dec 7, 1995 | K953987 | ACS TOURGIDE GUIDING CATHETER Advanced Cardiovascular Systems, Inc. | DQY |
| Nov 21, 1995 | K950490 | MEDTRONIC GC IV CORONARY GUIDING CATHETER Medtronics Interventional Vascular | DQY |
| Nov 13, 1995 | K953909 | SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER Scimed | DQY |
| Oct 23, 1995 | K954251 | 5F ENVOY GUIDING CATHETER (MODIFICATION) Cordis Neurovascular, Inc. | DQY |
| Oct 5, 1995 | K951603 | CARDIMA, INC. FORERUNNER Cardima, Inc. | DQY |
| Sep 25, 1995 | K951159 | FASGUIDE Target Therapeutics | DQY |
| Sep 19, 1995 | K953515 | SCIMED TRIGUIDE GUIDE CATHETERS Scimed Life Systems, Inc. | DQY |
| Aug 17, 1995 | K952345 | MEDI-TECH PLATFORM GUIDE CATHETER Medi-Tech, Inc. | DQY |
| Aug 4, 1995 | K952205 | ACS POWERBASE GUILDING CATHETER Advanced Cardiovascular Systems, Inc. | DQY |
| Aug 2, 1995 | K952185 | CORDIS BRITE TIP, ENVOY GUIDING CATHETER Cordis Corp. | DQY |
| Jul 25, 1995 | K950179 | MEDTRONIC(R) GC III CORONARY GUIDING CATHETER Medtronics Interventional Vascular | DQY |
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