Product code JOD
- Device name
- Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4270
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993060 | GAS FILTER | Olson Medical Sales, Inc. | 2000-03-28 |
| K890504 | CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS | Gish Biomedical, Inc. | 1989-03-10 |
| K875095 | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | 1988-02-29 |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | Pall Biomedical Products Co. | 1987-12-30 |
| K855067 | SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 | Cobe Laboratories, Inc. | 1986-02-26 |
| K841958 | CARDIO METRICS CARDIOTOMY RESERVOIR | Sterile Design, Inc. | 1984-10-15 |
| K830634 | CARDIOTOMY FILTER | Texas Medical Products, Inc. | 1983-06-30 |
| K823259 | INTERFACE CARDIOTOMY BLOOD FILTER #50 | Medical, Inc. | 1982-11-24 |
| K823260 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Medical, Inc. | 1982-11-24 |
| K812243 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Medical, Inc. | 1981-08-25 |
| K781383 | INTERFACE CARDIOTOMY BLOOD FILTER | Medical, Inc. | 1978-09-27 |
| K780653 | EXTRACORPEAL CARDIOTOMY BLOOD FILTER | Cobe Laboratories, Inc. | 1978-06-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04058863019222 | QUADROX-i | Maquet Cardiopulmonary AG | 2017-10-12 |
| 04037691838663 | VHK Venous Reservoir | Maquet Cardiopulmonary AG | 2017-03-13 |
| 04037691854984 | VHK reservoir Ad | Maquet Cardiopulmonary AG | 2017-03-13 |
| 04058863018843 | QUADROX-i | Maquet Cardiopulmonary AG | 2017-02-16 |
| 04058863007403 | QUADROX-i | Maquet Cardiopulmonary AG | 2017-02-16 |
| 04058863018867 | QUADROX-i | Maquet Cardiopulmonary AG | 2017-02-15 |
| 04058863005805 | QUADROX-i | Maquet Cardiopulmonary AG | 2017-02-15 |
| 30887691000301 | Cardioplegia Plus | HAEMONETICS CORPORATION | 2017-01-19 |
| 10887691000307 | Cardioplegia Plus | HAEMONETICS CORPORATION | 2017-01-19 |
| 04037692010006 | QUADROX-i | Maquet Cardiopulmonary AG | 2015-12-15 |
| 04037692011362 | QUADROX-i | Maquet Cardiopulmonary AG | 2015-12-15 |
| 04037692009994 | QUADROX-i | Maquet Cardiopulmonary AG | 2015-12-15 |
| 04037692010013 | QUADROX-i | Maquet Cardiopulmonary AG | 2015-12-15 |
| 04037692009987 | QUADROX-i | Maquet Cardiopulmonary AG | 2015-12-15 |
| 04037691965628 | QUADROX-i | Maquet Cardiopulmonary AG | 2015-10-24 |
| 04037691965307 | QUADROX-i | Maquet Cardiopulmonary AG | 2015-10-24 |
| 04037691913032 | QUADROX-i | Maquet Cardiopulmonary AG | 2015-10-24 |
| 04037691906942 | QUADROX-i | Maquet Cardiopulmonary AG | 2015-10-24 |
| 04037691833545 | NA | Maquet Cardiopulmonary AG | 2015-10-24 |