FDA Product Code
FDA Product Code DTN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4400
510(k) Clearances — 169 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K905818 | VACUUM-ASSISTED BLOOD COLLECTION SYSTEM | Jtl Medical Corp. | 1991-06-06 | Traditional | PDF ↗ |
| K902631 | COBE ICU CONVERSION KIT | Cobe Laboratories, Inc. | 1990-12-17 | Traditional | PDF ↗ |
| K903632 | INTERSEPT 1375 VENOUS RESERVOIR | Medtronic Vascular | 1990-12-17 | Traditional | PDF ↗ |
| K904040 | SOFTSHELL VENOUS RESERVOIR | C.R. Bard, Inc. | 1990-12-06 | Traditional | PDF ↗ |
| K894664 | CAPIOX HARDSHELL VENOUS RESERVOIR | Terumo Medical Corp. | 1990-04-20 | Traditional | PDF ↗ |
| K895356 | UNIVOX-IC | Baxter Healthcare Corp | 1990-03-06 | Traditional | PDF ↗ |
| K893711 | DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR | Shiley, Inc. | 1990-02-28 | Traditional | PDF ↗ |
| K896414 | VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN | Baxter Healthcare Corp | 1990-01-31 | Traditional | PDF ↗ |
| K893705 | SAFE-1 VENOUS RESERVOIR | Polystan C/O Vitalcor, Inc. | 1989-12-22 | Traditional | PDF ↗ |
| K895076 | CMS VRB-1200 | Cobe Laboratories, Inc. | 1989-11-03 | Traditional | PDF ↗ |
| K890077 | TRAUMAFUSE RAPID INFUSION DEVICE | The Traumafuse Co. | 1989-04-03 | Traditional | PDF ↗ |
| K884872 | DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR | Shiley, Inc. | 1989-01-30 | Traditional | PDF ↗ |
| K882414 | BLOOD RESERVOIR, CARDIOPULMONARY BYPASS | Gish Biomedical, Inc. | 1988-12-05 | Traditional | PDF ↗ |
| K883923 | CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES | Gish Biomedical, Inc. | 1988-11-04 | Traditional | PDF ↗ |
| K882380 | SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR | Scimed Life Systems, Inc. | 1988-10-06 | Traditional | PDF ↗ |
| K883345 | SARNS INFANT VENOUS RESERVOIR MODEL #16387 | 3M Health Care, Sarns | 1988-09-28 | Traditional | PDF ↗ |
| K882720 | SCIMED R30 SILICONE ASSIST RESERVOIR | Scimed Life Systems, Inc. | 1988-09-16 | Traditional | PDF ↗ |
| K873423 | MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER | Johnson & Johnson Professionals, Inc. | 1987-11-06 | Traditional | PDF ↗ |
| K872719 | EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER | Shiley, Inc. | 1987-09-30 | Traditional | PDF ↗ |
| K872721 | EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR | Shiley, Inc. | 1987-09-23 | Traditional | PDF ↗ |
| K872720 | SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET | Shiley, Inc. | 1987-09-23 | Traditional | PDF ↗ |
| K872722 | EXPANDED USE FOR SHILEY 3L CARDF PLUS | Shiley, Inc. | 1987-09-23 | Traditional | PDF ↗ |
| K872378 | WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR | C.R. Bard, Inc. | 1987-09-14 | Traditional | PDF ↗ |
| K871775 | STAT-VAC CHEST DRAINAGE SYSTEM | Gish Biomedical, Inc. | 1987-06-24 | Traditional | PDF ↗ |
| K870829 | SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR | 3M Health Care, Sarns | 1987-05-06 | Traditional | PDF ↗ |
| K864895 | INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER | Johnson & Johnson Professionals, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K862920 | BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR | C.R. Bard, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K862357 | MODIFIED CARDIOTOMY RESERVOIR 5M1470 | 3M Health Care, Sarns | 1986-08-19 | Traditional | PDF ↗ |
| K854841 | SHILEY VENOUS RESERVOIR | Shiley, Inc. | 1986-02-10 | Traditional | PDF ↗ |
| K852382 | CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR | American Bentley | 1985-09-25 | Traditional | PDF ↗ |
| K851401 | VENUOS RESERVOIR BAG BMR-1900 | American Bentley | 1985-06-25 | Traditional | PDF ↗ |
| K851376 | VENOUS RESERVOIR BAG BMR-1600 | American Bentley | 1985-06-25 | Traditional | PDF ↗ |
| K842391 | ACR 2500 CARDIOTOMY RESERVOIR FILTER | Electromedics, Inc. | 1985-05-21 | Traditional | PDF ↗ |
| K843595 | CARDIOTOMY RESERVOIR W/FILTER | Omnis Surgical, Inc. | 1985-02-14 | Traditional | PDF ↗ |
| K843888 | CARDIOTOMY RESERVOIR BRS-XXX SERIES & | Gish Biomedical, Inc. | 1985-02-14 | Traditional | PDF ↗ |
| K844367 | CARDIOTOMY RESERVOIR W/FILTER BCR-2500 | American Bentley | 1985-01-14 | Traditional | PDF ↗ |
| K844366 | CARDIOTOMY RESERVOIR BCR-2000 | American Bentley | 1985-01-14 | Traditional | PDF ↗ |
| K844229 | VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX | Gish Biomedical, Inc. | 1985-01-14 | Traditional | PDF ↗ |
| K843232 | SHILEY HARDSHELL VENOUS RESERVOIR W/INT | Shiley, Inc. | 1985-01-14 | Traditional | PDF ↗ |
| K842620 | CARDIOTOMY RESERVOIR W/FILTER BCR-3500 | American Bentley | 1984-08-27 | Traditional | PDF ↗ |
| K842337 | SHILEY VENOUS RESERVOIR | Shiley, Inc. | 1984-08-17 | Traditional | PDF ↗ |
| K842711 | SHILEY CARDIOTOMY RESERVOIR W/FILTER | Shiley, Inc. | 1984-08-10 | Traditional | PDF ↗ |
| K841938 | CARDIOPLEGIA RESERVOIR CAS-2000 | American Bentley | 1984-08-03 | Traditional | PDF ↗ |
| K841031 | OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT | American Bentley | 1984-05-23 | Traditional | PDF ↗ |
| K841175 | WILLIAM HARVEY H-4720 NON-FILTERED CAR | C.R. Bard, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K841079 | WILLIAM HARVEY H-4700 FILTER/CARDIO | C.R. Bard, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K834373 | CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 | American Bentley | 1984-02-04 | Traditional | PDF ↗ |
| K832802 | USE OF TWEEN 80 AS A WETTING AGENT ON | American Bentley | 1983-12-29 | Traditional | PDF ↗ |
| K832671 | CARDIOTOMY RESERVOIR-FILTER 050-108-050 | Cobe Laboratories, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K833479 | WILLIAM HARVEY H-71-5-F CARDIOTOMY | C.R. Bard, Inc. | 1983-12-16 | Traditional | PDF ↗ |
| K832924 | VENOUS RESERVOIR | Shiley, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K831966 | CARDIOPLEGIA RESERVOIR-#500926 | American Bentley | 1983-08-11 | Traditional | PDF ↗ |
| K823272 | VENOUS RESERVOIR BAG #BMR-1400 | Bentley Laboratories, Inc. | 1982-12-30 | Traditional | PDF ↗ |
| K823205 | EXV VENOUS RESERVOIR BAG & HOLDER | Extracorporeal Medical Specialities, Inc. | 1982-11-24 | Traditional | PDF ↗ |
| K820727 | CARDIOTOMY RESERVOIRS | Erik Perfusion Services | 1982-07-08 | Traditional | PDF ↗ |
| K821442 | WILLIAM HARVEY FLEX. VENOUS RESERVOIR | C.R. Bard, Inc. | 1982-06-17 | Traditional | PDF ↗ |
| K813268 | SC-2500F CARDIOTOMY RESERVIOR | Scimed Life Systems, Inc. | 1982-05-18 | Traditional | PDF ↗ |
| K812455 | SUCKER CARDIOTOMY RETURN, C.P. BYPASS | Electromedics, Inc. | 1981-10-23 | Traditional | PDF ↗ |
| K812008 | CORDIOTOMY RESERVOIR | Bentley Laboratories, Inc. | 1981-07-28 | Traditional | PDF ↗ |
| K812009 | CARDIOTOMY RESERVOIR W/FILTER#BCR-3500 | Bentley Laboratories, Inc. | 1981-07-28 | Traditional | PDF ↗ |
| K802890 | CPS-1000 | Gics Pharmaceuticals | 1981-03-05 | Traditional | PDF ↗ |
| K803059 | INTERSEPT* VENOUS RESERVOIR BAG & HOLDER | Extracorporeal Medical Specialities, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K802119 | SHILEY UTILITY RESERVOIR | Shiley, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K790635 | Q220F CARDITOMY RESERVOIR/MODIFIED | Bentley Laboratories, Inc. | 1979-04-18 | Traditional | PDF ↗ |
| K781577 | DISPOSABLE CARDIOTOMY; H-700F, H-700 | C.R. Bard, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K780517 | CARDIOTOMY RESERVOIR | Travenol Laboratories, S.A. | 1978-04-13 | Traditional | PDF ↗ |
| K770546 | BLOOD RESERVOIR | Delta Medical Industries | 1977-04-26 | Traditional | PDF ↗ |
| K770036 | CARDIOTOMY RESERVOIR | Shiley, Inc. | 1977-01-14 | Traditional | PDF ↗ |
| K760823 | TMO OXYGENATOR RESERVOIR PUMP SET | Travenol Laboratories, S.A. | 1976-11-12 | Traditional | PDF ↗ |
Product code DTN · Class II · Cardiovascular. Data: openFDA.