Panels › Cardiovascular › Product code DQO · Class 2
Catheter, Intravascular, Diagnostic
Regulation 870.1200
3510(k)s in 12 months (501 all time)
26recalls in 12 months (285 all time)
246recalls that name a 510(k)
Top companies in DQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 15 | 85 |
| Boston Scientific Corp | 20 | 73 |
| Merit Medical Systems, Inc. | 8 | 33 |
| Cordis Corp. | 29 | 8 |
| AngioDynamics, Inc. | 11 | 23 |
| Vascular Solutions, Inc. | 12 | 10 |
| C.R. Bard, Inc. | 16 | 0 |
| Scimed Life Systems, Inc. | 16 | 0 |
| LeMaitre Vascular, Inc. | 0 | 12 |
| Target Therapeutics | 10 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 31, 1994 | K936260 | TRANSIT INFUSION CATHETER Cordis Corp. | DQO |
| May 12, 1994 | K935403 | WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD J-Lloyd Medical, Inc. | DQO |
| May 12, 1994 | K934541 | SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION Scimed Life Systems, Inc. | DQO |
| Apr 26, 1994 | K935402 | ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD J-Lloyd Medical, Inc. | DQO |
| Mar 31, 1994 | K934581 | SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc. | DQO |
| Mar 23, 1994 | K925813 | DIAGNOSTIC INTRAVASCULAR CATHETER Target Therapeutics | DQO |
| Feb 22, 1994 | K935654 | SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH Scimed Life Systems, Inc. | DQO |
| Dec 6, 1993 | K931629 | CARAPACE ANGIOGRAPHY TRAYS Carapace, Inc. | DQO |
| Nov 4, 1993 | K930081 | OHMEDA ADAPTABLE CABLE W/DETACHABLE SENSOR Ohmeda Monitoring Systems | DQO |
| Nov 3, 1993 | K933700 | DYE MANAGEMENT SYSTEM Abbott Laboratories | DQO |
| Oct 6, 1993 | K931479 | SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Medical | DQO |
| Sep 28, 1993 | K931833 | MODIFIED LUER Medi-Dyne, Inc. | DQO |
| Aug 27, 1993 | K932218 | CARDIAC CATH OR ANGIOGRAPHIC TRAYS Associated Medical Products Co. | DQO |
| Aug 17, 1993 | K932420 | SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING Scimed Life Systems, Inc. | DQO |
| Aug 16, 1993 | K926243 | ANGIOGRAPHIC CATHETER Target Therapeutics | DQO |
| Aug 11, 1993 | K932542 | SCIMED 6F ANGIOGRAPHIC CATHETER Scimed Life Systems, Inc. | DQO |
| Aug 2, 1993 | K930694 | MEDI-DYNE ANGIOGRAPHIC CATHETER Medi-Dyne, Inc. | DQO |
| Jul 29, 1993 | K932092 | USCI ANGIOGRAPHIC CATHETER C.R. Bard, Inc. | DQO |
| Jul 21, 1993 | K930232 | CVIS INSIGHT IMAGING GUIDE CATHETER Cardiovascular Imaging Systems, Inc. | DQO |
| Jun 29, 1993 | K925632 | BALT GUIDING CATHETER Target Therapeutics | DQO |
| Jun 29, 1993 | K924922 | CVIS INSIGHT IMAGING CATHETER Cardiovascular Imaging Systems, Inc. | DQO |
| Jun 23, 1993 | K922891 | CORDIS 7 FRENCH THRULUMEN CATHETER Cordis Corp. | DQO |
| Jun 7, 1993 | K926003 | SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER Schneider Intl., Ltd. | DQO |
| Jun 2, 1993 | K930311 | CVIS LONGVIEW Cardiovascular Imaging Systems, Inc. | DQO |
| Apr 21, 1993 | K930479 | NYLEX CATHETERS Cordis Corp. | DQO |
| Mar 11, 1993 | K921649 | RETRIEVER 10 Target Therapeutics | DQO |
| Mar 3, 1993 | K922552 | MORSE(R) ANGIOGRAPHIC CATHETERS North American Instrument Corp. | DQO |
| Feb 12, 1993 | K922101 | ANGIOGRAPHIC CATHETER -- MODIFICATION Interventional Therapeutics Corp. | DQO |
| Jan 14, 1993 | K920873 | WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD J-Lloyd Medical, Inc. | DQO |
| Jan 7, 1993 | K920870 | ANGIOGRAPHIC BALLOON CATHETER BY J LLOYD J-Lloyd Medical, Inc. | DQO |
| Dec 21, 1992 | K923699 | DIAGNOSTIC INTRAVASCULAR CATHETER Applied Vascular | DQO |
| Dec 3, 1992 | K922484 | COBE SAMPLING SITE Cobe Cardiovascular, Inc. | DQO |
| Nov 17, 1992 | K922105 | USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING C.R. Bard, Inc. | DQO |
| Nov 10, 1992 | K921845 | INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT Becton Dickinson Vascular Access, Inc. | DQO |
| Oct 6, 1992 | K923480 | SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA Scimed Life Systems, Inc. | DQO |
| Sep 21, 1992 | K915726 | PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH Baxter Healthcare Corp | DQO |
| Sep 17, 1992 | K921310 | CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER Cordis Corp. | DQO |
| Sep 1, 1992 | K922254 | LUKENS 2-0 BRAIDED SILK SUTURES Quinton, Inc. | DQO |
| Aug 24, 1992 | K920980 | USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT C.R. Bard, Inc. | DQO |
| Aug 5, 1992 | K912270 | POLYCATH #WMC-900 Worldwide Medical | DQO |
| Jul 16, 1992 | K921879 | CBIS CATHETER PULL-BACK DEVICE Cardiovascular Imaging Systems, Inc. | DQO |
| Jun 29, 1992 | K915351 | SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER Medtronics Interventional Vascular | DQO |
| Jun 3, 1992 | K914299 | CARDIAC CATHERIZATION KIT Abbott Laboratories | DQO |
| Apr 17, 1992 | K915498 | CORDIS ANGIOGRAPHIC DOPPLER CATHER Cordis Corp. | DQO |
| Apr 7, 1992 | K920408 | DESERET GUIDEWIRE INTRODUCER III Bd Becton Dickinson Vacutainer Systems Preanalytic | DQO |
| Apr 7, 1992 | K920407 | DESERET GUIDEWIRE INTRODUCER II Bd Becton Dickinson Vacutainer Systems Preanalytic | DQO |
| Feb 11, 1992 | K915836 | CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS Cordis Corp. | DQO |
| Feb 4, 1992 | K915414 | TERUMO ANGIOGTAPHIC CATHETER Terumo Medical Corp. | DQO |
| Jan 27, 1992 | K915136 | ATRAUMATIC TIP ANGIOGRAPHIC CATHETER Exonix Research Corp. | DQO |
| Jan 27, 1992 | K913094 | DISPOSABLE SLIDE VALVE MANIFOLD Professional Medical Services | DQO |
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