DWD — Suction Control, Intracardiac, Cardiopulmonary Bypass Class II
FDA product code DWD covers "Suction Control, Intracardiac, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4430. Submissions are reviewed by the Cardiovascular panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DWD
- Device Class
- Class II
- Regulation Number
- 870.4430
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K992657 | international biophysics | IBC VRV, MODEL 1350 | February 18, 2000 |
| K920077 | international medical products | NIKKISO NK PUMP | September 29, 1993 |
| K915482 | bd becton dickinson vacutainer systems preanalytic | B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT | January 7, 1992 |
| K915481 | bd becton dickinson vacutainer systems preanalytic | B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT | January 7, 1992 |
| K915480 | bd becton dickinson vacutainer systems preanalytic | B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. | January 7, 1992 |
| K905311 | baxter bentley laboratories | DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. | January 15, 1991 |
| K895427 | deroyal industries | MEDISEAL SUCTION CANISTER | January 19, 1990 |
| K864503 | american omni medical | MODIFIED RLV-2100 B | January 6, 1987 |
| K863593 | 3m health care, sarns | SARNS SAFETY LOOP | November 18, 1986 |
| K862540 | gish biomedical | LEFT VENTRICULAR VENT VALVE MODEL NO. GLV | August 29, 1986 |
| K861428 | american omni medical | SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 | June 26, 1986 |
| K851406 | american omni medical | AJDJUSTABLE SUCTION CONTROL VALVE | August 5, 1985 |
| K830149 | instrumentation laboratory | IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- | February 28, 1983 |
| K830150 | atrium medical | VEINPREP VEIN GRAFT PREP. KIT A277723 | February 28, 1983 |
| K760894 | delta medical industries | VACUUM RELIEF VALVE | December 9, 1976 |