Panels › Cardiovascular › Product code DWD · Class 2
Suction Control, Intracardiac, Cardiopulmonary Bypass
Regulation 870.4430
0510(k)s in 12 months (15 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DWD
| Company | 510(k)s | Recalls |
|---|---|---|
| American Omni Medical, Inc. | 3 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 0 |
| 3M Health Care, Sarns | 1 | 0 |
| Atrium Medical Corp. | 1 | 0 |
| Baxter Bentley Laboratories, Inc. | 1 | 0 |
| Delta Medical Industries | 1 | 0 |
| Deroyal Industries, Inc. | 1 | 0 |
| Gish Biomedical, Inc. | 1 | 0 |
| Instrumentation Laboratory CO | 1 | 0 |
| International Biophysics Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 2000 | K992657 | IBC VRV, MODEL 1350 International Biophysics Corp. | DWD |
| Sep 29, 1993 | K920077 | NIKKISO NK PUMP International Medical Products, Inc. | DWD |
| Jan 7, 1992 | K915482 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT Bd Becton Dickinson Vacutainer Systems Preanalytic | DWD |
| Jan 7, 1992 | K915481 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT Bd Becton Dickinson Vacutainer Systems Preanalytic | DWD |
| Jan 7, 1992 | K915480 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. Bd Becton Dickinson Vacutainer Systems Preanalytic | DWD |
| Jan 15, 1991 | K905311 | DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. Baxter Bentley Laboratories, Inc. | DWD |
| Jan 19, 1990 | K895427 | MEDISEAL SUCTION CANISTER Deroyal Industries, Inc. | DWD |
| Jan 6, 1987 | K864503 | MODIFIED RLV-2100 B American Omni Medical, Inc. | DWD |
| Nov 18, 1986 | K863593 | SARNS SAFETY LOOP 3M Health Care, Sarns | DWD |
| Aug 29, 1986 | K862540 | LEFT VENTRICULAR VENT VALVE MODEL NO. GLV Gish Biomedical, Inc. | DWD |
| Jun 26, 1986 | K861428 | SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 American Omni Medical, Inc. | DWD |
| Aug 5, 1985 | K851406 | AJDJUSTABLE SUCTION CONTROL VALVE American Omni Medical, Inc. | DWD |
| Feb 28, 1983 | K830150 | VEINPREP VEIN GRAFT PREP. KIT A277723 Atrium Medical Corp. | DWD |
| Feb 28, 1983 | K830149 | IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- Instrumentation Laboratory CO | DWD |
| Dec 9, 1976 | K760894 | VACUUM RELIEF VALVE Delta Medical Industries | DWD |
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