Product code DWD
- Device name
- Suction Control, Intracardiac, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4430
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992657 | IBC VRV, MODEL 1350 | International Biophysics Corp. | 2000-02-18 |
| K920077 | NIKKISO NK PUMP | International Medical Products, Inc. | 1993-09-29 |
| K915480 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-01-07 |
| K915481 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-01-07 |
| K915482 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-01-07 |
| K905311 | DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. | Baxter Bentley Laboratories, Inc. | 1991-01-15 |
| K895427 | MEDISEAL SUCTION CANISTER | Deroyal Industries, Inc. | 1990-01-19 |
| K864503 | MODIFIED RLV-2100 B | American Omni Medical, Inc. | 1987-01-06 |
| K863593 | SARNS SAFETY LOOP | 3M Health Care, Sarns | 1986-11-18 |
| K862540 | LEFT VENTRICULAR VENT VALVE MODEL NO. GLV | Gish Biomedical, Inc. | 1986-08-29 |
| K861428 | SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 | American Omni Medical, Inc. | 1986-06-26 |
| K851406 | AJDJUSTABLE SUCTION CONTROL VALVE | American Omni Medical, Inc. | 1985-08-05 |
| K830149 | IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- | Instrumentation Laboratory CO | 1983-02-28 |
| K830150 | VEINPREP VEIN GRAFT PREP. KIT A277723 | Atrium Medical Corp. | 1983-02-28 |
| K760894 | VACUUM RELIEF VALVE | Delta Medical Industries | 1976-12-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10634624431031 | VRV-II Vacuum Relief Valve | QUEST MEDICAL INC | 2017-09-29 |
| 10634624441030 | VRV-IIC Clear Vacuum Relief Valve | QUEST MEDICAL INC | 2017-09-29 |
| 00634624413122 | "RLV-2100 ""B"" Vacuum Relief Valve" | QUEST MEDICAL INC | 2017-09-29 |
| 00634624431058 | RLV-T Suction Control Device | QUEST MEDICAL INC | 2017-09-29 |
| 20634624413225 | "RLV-2100""B"" Vacuum Relief Valve" | QUEST MEDICAL INC | 2017-09-29 |
| 20634624413256 | RLV-T Suction Control Device_Nonsterile | QUEST MEDICAL INC | 2017-09-29 |
| 20634624413126 | RLV-2100 "B" Vacuum Relief Valve | QUEST MEDICAL INC | 2017-09-29 |
| 20634624431052 | RLV-T Suction Control Device | QUEST MEDICAL INC | 2017-09-29 |
| 10634624432038 | VRV-II Vacuum Relief Valve | QUEST MEDICAL INC | 2017-09-22 |
| 10634624442037 | VRV-II Clear Vacuum Relief Valve - Nonsterile | QUEST MEDICAL INC | 2017-09-22 |