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 |
|---|---|---|---|
| Jan 17, 1992 | K911270 | LEOCOR GUIDING CATHETER Leocor, Inc. | DQO |
| Dec 18, 1991 | K914208 | MERIT DISPOSAL DEPOT(TM) Merit Medical Systems, Inc. | DQO |
| Dec 18, 1991 | K914199 | ANGIOGRAPHIC SOFT TIP CATHETER E-Z-Em, Inc. | DQO |
| Dec 11, 1991 | K912532 | ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH Interventional Therapeutics Corp. | DQO |
| Dec 10, 1991 | K914067 | RETRIEVAL DEVICE Target Therapeutics | DQO |
| Dec 6, 1991 | K914009 | SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER Schneider Intl., Ltd. | DQO |
| Nov 27, 1991 | K914128 | CONNECTING SET Procedure Products, Inc. | DQO |
| Nov 25, 1991 | K913871 | FLOSWITCH(R) HP Boston Scientific Corp | DQO |
| Nov 22, 1991 | K914312 | SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS Scimed Life Systems, Inc. | DQO |
| Nov 15, 1991 | K913682 | MERIT CUSTOM KIT Merit Medical Systems, Inc. | DQO |
| Nov 5, 1991 | K912477 | ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION Interventional Therapeutics Corp. | DQO |
| Oct 31, 1991 | K913397 | MEGA ANGIOGRAM KIT Mega Medical, Inc. | DQO |
| Oct 23, 1991 | K914141 | CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER Cordis Corp. | DQO |
| Oct 23, 1991 | K911710 | HEPARIN COATED THERMODILUTION CATH & ACCESSORIES Sunscope Intl., Inc. | DQO |
| Oct 18, 1991 | K914007 | CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH Cordis Corp. | DQO |
| Sep 6, 1991 | K911957 | ACS RX SUPPORT CATHETER Advanced Cardiovascular Systems, Inc. | DQO |
| Aug 30, 1991 | K913364 | SCIMED 7 FR. & 8 FR. Scimed Life Systems, Inc. | DQO |
| Jul 30, 1991 | K912076 | POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF The R Group | DQO |
| Jul 9, 1991 | K911605 | TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES Target Therapeutics | DQO |
| Jul 5, 1991 | K911560 | ZEPHYR INFUSION CATHETER Target Therapeutics | DQO |
| Jun 28, 1991 | K911703 | CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER Cordis Corp. | DQO |
| Jun 10, 1991 | K911367 | BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH Baxter Healthcare Corp | DQO |
| May 29, 1991 | K910987 | 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE Scimed | DQO |
| Apr 24, 1991 | K910204 | SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) Baxter Healthcare Corp | DQO |
| Apr 22, 1991 | K910378 | PRESSURE MONITORING EXTENSION LINE Professional Medical Services | DQO |
| Apr 18, 1991 | K910259 | SCHNEIDER MAGNARAIL PROBING CATHETER Schneider Intl., Ltd. | DQO |
| Apr 12, 1991 | K904618 | CVIS INSIGHT IMAGING CATHETER Cardiovascular Imaging Systems, Inc. | DQO |
| Apr 1, 1991 | K910208 | BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS Baxter Healthcare Corp | DQO |
| Mar 25, 1991 | K903848 | DIAGNOSTIC INTRASCULAR CATHETER Applied Vascular Devices, Inc. | DQO |
| Mar 18, 1991 | K905715 | ACS ANGIOSCOPIC CATHETER Advanced Cardiovascular Systems, Inc. | DQO |
| Feb 21, 1991 | K905625 | CVIS INSIGHT IMAGING CATHETER Cardiovascular Imaging Systems, Inc. | DQO |
| Feb 11, 1991 | K905499 | SCIMD 7 FR. TRIGUIDE GUIDING CATHETER Scimed Life Systems, Inc. | DQO |
| Feb 1, 1991 | K905727 | USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER C.R. Bard, Inc. | DQO |
| Feb 1, 1991 | K905297 | DIAVENTIONAL CATHETER Cordis Corp. | DQO |
| Feb 1, 1991 | K904491 | TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 Lifestream Int'L, Inc. | DQO |
| Jan 16, 1991 | K905018 | LAB-SITE SAFETY NEEDLE Telos Medical Corp. | DQO |
| Jan 15, 1991 | K905017 | LAB-SITE Telos Medical Corp. | DQO |
| Dec 17, 1990 | K904959 | PSG HEMOSTATIC CONTROL VALVE Peripheral Systems Group | DQO |
| Dec 17, 1990 | K904788 | MEWISSEN CATHETER Boston Scientific Corp | DQO |
| Dec 17, 1990 | K903199 | HOLLOW LUMEN NEEDLE, PART NUMBER: MX920 Medex, Inc. | DQO |
| Dec 17, 1990 | K892671 | WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER Wilson Biomedical, Inc. | DQO |
| Nov 5, 1990 | K902771 | ARTERIAL BLOOD SAMPLING KIT Medex, Inc. | DQO |
| Oct 3, 1990 | K902943 | RSI FEMORAL GUIDING CATHETER Retroperfusion Systems, Inc. | DQO |
| Sep 28, 1990 | K902953 | SOFTOUCH GUIDING CATHETER Mallinckrodt Medical | DQO |
| Jul 17, 1990 | K900460 | MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER Novoste Corp. | DQO |
| Jul 6, 1990 | K901691 | CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE Cardiovascular Imaging Systems, Inc. | DQO |
| Jun 28, 1990 | K895437 | SCIMED CORONARY GUIDING CATHETER Scimed Life Systems, Inc. | DQO |
| Apr 23, 1990 | K895180 | USCI 7F LARGE LUMEN GUIDING CATHETER C.R. Bard, Inc. | DQO |
| Apr 19, 1990 | K894401 | BALLOON THERMODILUTION CATHETERS Worldwide Medical | DQO |
| Apr 6, 1990 | K895542 | SONICATH(TM) 5 F Boston Scientific Corp | DQO |
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