FDA Product Code
FDA Product Code DTP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4230
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101186 | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG | Medtronic Perfusion Systems | 2010-09-03 | Traditional | PDF ↗ |
| K082412 | VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 | Mapquet Cardiopulmonary AG | 2008-11-10 | Traditional | PDF ↗ |
| K004046 | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | 2001-04-26 | Traditional | PDF ↗ |
| K002591 | COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | 2000-09-13 | Special | PDF ↗ |
| K990514 | MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR | C.R. Bard, Inc. | 1999-03-09 | Special | PDF ↗ |
| K984322 | DIDECO D920, LILLIPUT 1 TWIN RESERVOIR | Dideco S.P.A. | 1999-03-02 | Traditional | PDF ↗ |
| K962726 | BARD QUANTUM CVR | C.R. Bard, Inc. | 1996-10-30 | Traditional | PDF ↗ |
| K941654 | SARNS FILTERED VENOUS RESERVIOR MODIFICATION | 3M Health Care, Sarns | 1994-07-26 | Traditional | PDF ↗ |
| K933496 | MAXIMA FILTERED HARDSHELL RESERVIOR | Medtronic Vascular | 1993-10-15 | Traditional | PDF ↗ |
| K912915 | SARNS NON-FILTERED VENOUS RESERVOIR | 3M Health Care, Ltd. | 1991-09-25 | Traditional | PDF ↗ |
| K911789 | MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT | Medtronic Vascular | 1991-08-20 | Traditional | PDF ↗ |
| K910568 | MODEL 5866-46 SLEEVE KIT | Medtronic Vascular | 1991-04-09 | Traditional | PDF ↗ |
| K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | Cobe Laboratories, Inc. | 1990-12-17 | Traditional | PDF ↗ |
| K902856 | BARD FILTERED CARDIOTOMY RESERVOIR | C.R. Bard, Inc. | 1990-09-27 | Traditional | PDF ↗ |
| K902355 | MCR4000 & MCR4000F CARDIOTOMY RESERVOIR | Medtronic Vascular | 1990-08-23 | Traditional | PDF ↗ |
| K874924 | CAP-35 AND CAP35 F | Gish Biomedical, Inc. | 1988-01-19 | Traditional | PDF ↗ |
| K872167 | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | American Bentley | 1987-09-01 | Traditional | PDF ↗ |
| K870792 | THORASTAT ATR-XXXX | Gish Biomedical, Inc. | 1987-04-28 | Traditional | PDF ↗ |
| K860702 | SARNS FILTERED CARDIOTOMY RESERVOIR | 3M Health Care, Sarns | 1986-05-28 | Traditional | PDF ↗ |
| K860775 | MEDIASTINAL AUTOTRANSFUSION SYSTEM | Cardio Metrics, Inc. | 1986-05-28 | Traditional | PDF ↗ |
| K855049 | MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR | Scimed Life Systems, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K853503 | SHILEY 3L CARDIOTOMY RESERVOIR | Shiley, Inc. | 1985-11-14 | Traditional | PDF ↗ |
| K851004 | CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX | Gish Biomedical, Inc. | 1985-05-16 | Traditional | PDF ↗ |
| K844803 | POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE | Electromedics, Inc. | 1985-04-29 | Traditional | PDF ↗ |
| K842373 | VENOUS RESERVOIR-BMR-1500-HARD SHELL | American Bentley | 1984-12-27 | Traditional | PDF ↗ |
| K840610 | SCIMED MODEL SC4000 | Scimed Life Systems, Inc. | 1984-04-24 | Traditional | PDF ↗ |
| K834041 | CARDIOTOMY RESERVOIR SC3500F | Scimed Life Systems, Inc. | 1984-01-30 | Traditional | PDF ↗ |
| K832811 | SHILEY 3L CARDF PLUS | Shiley, Inc. | 1983-09-20 | Traditional | PDF ↗ |
| K830727 | CARDIOTOMY RESERVOIR-FILTERED & NON | Electromics, Inc. | 1983-04-05 | Traditional | PDF ↗ |
| K823731 | CARDF | Shiley, Inc. | 1983-01-05 | Traditional | PDF ↗ |
| K821538 | CAPIOX CR-CARDIOTOMY RESERVOIR | Terumo Medical Corp. | 1982-08-06 | Traditional | PDF ↗ |
| K820954 | SCIMED MODEL SC 3000 | Scimed Life Systems, Inc. | 1982-05-24 | Traditional | PDF ↗ |
| K801360 | CARDIOTOMY RESERVOIR WITH FILTER | Travenol Laboratories, S.A. | 1980-07-14 | Traditional | PDF ↗ |
| K801375 | SHILEY CARDIOTOMY RESERVOIR W/FILTER | Shiley, Inc. | 1980-07-14 | Traditional | PDF ↗ |
Product code DTP · Class II · Cardiovascular. Data: openFDA.