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 |
|---|---|---|---|
| Mar 28, 1990 | K896308 | CORDIS SHUTTLE CATHETER Cordis Corp. | DQO |
| Mar 16, 1990 | K897051 | MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH Cathlab Corp. | DQO |
| Feb 28, 1990 | K896741 | SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH. Schneider Intl., Ltd. | DQO |
| Jan 24, 1990 | K896690 | MODIFIED ANGIOGRAPHIC CATHETER Novoste Corp. | DQO |
| Jan 19, 1990 | K895146 | GUIDING CATHETER Peripheral Systems Group | DQO |
| Dec 28, 1989 | K885221 | MULTILUMEN CENTRAL VENOUS CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic | DQO |
| Dec 20, 1989 | K893877 | BIOCHEM 3100 OXIMETER Biochem International, Inc. | DQO |
| Nov 27, 1989 | K894168 | SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F Baxter Healthcare Corp | DQO |
| Nov 6, 1989 | K895268 | ARROW HANDS-OFF THERMO-PACE Arrow Intl., Inc. | DQO |
| Oct 12, 1989 | K893830 | HEMO-ALERT Koregon Enterprise, Inc. | DQO |
| Aug 3, 1989 | K891580 | INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING Boston Scientific Corp | DQO |
| May 19, 1989 | K890206 | E-Z-FLOW ANGIOGRAPHY CATHETERS E-Z-Em, Inc. | DQO |
| May 15, 1989 | K885348 | A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL Mallinckroot, Inc. | DQO |
| Apr 24, 1989 | K890420 | USCI 7F GUIDE CATHETER C.R. Bard, Inc. | DQO |
| Apr 21, 1989 | K884354 | IMAGER FLUSH CATHETERS Medi-Tech, Inc. | DQO |
| Jan 26, 1989 | K882658 | ANGIOSCOPE FOR PULMONARY ARTERY USE Washington Regulatory Services | DQO |
| Jan 18, 1989 | K884502 | USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER C.R. Bard, Inc. | DQO |
| Jan 12, 1989 | K884065 | CATH LAB MONITORING CATHETER C.R. Bard, Inc. | DQO |
| Nov 18, 1988 | K883651 | MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER Millar Instruments, Inc. | DQO |
| Oct 6, 1988 | K883051 | USCI SOFT-TIP ANGIOGRAPHIC CATHETER C.R. Bard, Inc. | DQO |
| Sep 16, 1988 | K882655 | PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE Procedure Packs, Inc. | DQO |
| Aug 9, 1988 | K875127 | NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS Novoste Corp. | DQO |
| Jul 28, 1988 | K882796 | SLIP-COAT(TM) CATHETERS Cook, Inc. | DQO |
| May 25, 1988 | K875337 | HEPARIN COATED LUMINAL PACING CATHETER Spectramed, Inc. | DQO |
| May 2, 1988 | K880661 | FIBEROPTIC CATHETER Optimed Technologies, Inc. | DQO |
| Feb 18, 1988 | K875326 | MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER Schneider-Shilley (Usa) | DQO |
| Feb 18, 1988 | K875325 | MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK Schneider-Shilley (Usa) | DQO |
| Feb 5, 1988 | K874815 | TARGET THERAPEUTICS STERILE PRODUCTS Target Therapeutics | DQO |
| Jan 29, 1988 | K874037 | ANGIO WASTE FLUIDS DUMP BAG Procedure Products, Inc. | DQO |
| Dec 3, 1987 | K870700 | MICRO-GUIDE Catheter Research C/O Burditt, Bowles & Radzius | DQO |
| Nov 27, 1987 | K873438 | USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER C.R. Bard, Inc. | DQO |
| Sep 15, 1987 | K873004 | GUIDING CATHETER Mallinckrodt Critical Care | DQO |
| Aug 12, 1987 | K872248 | DOUBLE LUMEN CATHETER Cordis Corp. | DQO |
| Jun 16, 1987 | K871021 | GUIDING CATHETERS 9F JL4 Devices For Vascular Intervention, Inc. | DQO |
| May 11, 1987 | K870419 | IVR-SP CUSTOM ANGIOGRAPHY TRAY North Coast Medi-Tek | DQO |
| Feb 20, 1987 | K864943 | NUMED BALLOON WEDGE PRESSURE CATHETER NuMED, Inc. | DQO |
| Feb 19, 1987 | K864940 | NUMED BALLOON ANGIOGRAPHIC CATHETERS NuMED, Inc. | DQO |
| Jan 6, 1987 | K861241 | ANGIOTOPO CATHETER Houston Biomedical, Inc. | DQO |
| Nov 10, 1986 | K852547 | CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON Cortronic Corp. | DQO |
| Nov 3, 1986 | K864141 | CORDIS CONTRAST INJECTION LINES Cordis Corp. | DQO |
| Oct 10, 1986 | K863137 | TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER Terumo Medical Corp. | DQO |
| Sep 29, 1986 | K863337 | CORDIPAK CARDIAC CATHETERIZATION PACK Angi-Pak Corp. | DQO |
| Sep 11, 1986 | K862673 | MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER Medtronic Vascular | DQO |
| Aug 29, 1986 | K862466 | SCHNEIDER-SHILEY FLUSHING CATHETER Shiley, Inc. | DQO |
| Aug 28, 1986 | K862464 | SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR Shiley, Inc. | DQO |
| Aug 25, 1986 | K862244 | MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS Cordis Corp. | DQO |
| Aug 11, 1986 | K862465 | SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK Shiley, Inc. | DQO |
| Aug 8, 1986 | K862030 | POLY-TECH ANGIOGRAPHY CATHETER Poly-Tech Medical Device Research & Development | DQO |
| Jul 17, 1986 | K854910 | ANGIOFLOW Angiomed U.S., Inc. | DQO |
| Jul 10, 1986 | K861236 | ACS CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. | DQO |
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