510(k) K004046
- Device
- COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
- Applicant
- COBE CARDIOVASCULAR, INC.
- 510(k) number
- K004046
- Product code
- DTP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-04-26
- Date received
- 2000-12-29
- Regulation
- 870.4230
- Classification name
- Defoamer, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNNE LEONARD
- Address
- 14401 W. 65th Way Arvada CO US 80004 80004
FDA Registration Numbers#
- 9680841
- 1928237
- 9617601
- 2184009
- 1643817
- 3011554160
- 1319639
- 3005941719
- 3019807891
- 1625519
- 1124841
- 2029275
- 2011171
Source Documents#
Other 510(k) Records For Product Code DTP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101186 | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG | Medtronic Perfusion Systems | 2010-09-03 |
| 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 |
| K002591 | COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | 2000-09-13 |
| K990514 | MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR | C.R. Bard, Inc. | 1999-03-09 |
| K984322 | DIDECO D920, LILLIPUT 1 TWIN RESERVOIR | Dideco S.P.A. | 1999-03-02 |
| K962726 | BARD QUANTUM CVR | C.R. Bard, Inc. | 1996-10-30 |
| K941654 | SARNS FILTERED VENOUS RESERVIOR MODIFICATION | 3M Health Care, Sarns | 1994-07-26 |
| K933496 | MAXIMA FILTERED HARDSHELL RESERVIOR | Medtronic Vascular | 1993-10-15 |
| K912915 | SARNS NON-FILTERED VENOUS RESERVOIR | 3M Health Care, Ltd. | 1991-09-25 |
| K911789 | MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT | Medtronic Vascular | 1991-08-20 |
| K910568 | MODEL 5866-46 SLEEVE KIT | Medtronic Vascular | 1991-04-09 |
| K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | Cobe Laboratories, Inc. | 1990-12-17 |
| K902856 | BARD FILTERED CARDIOTOMY RESERVOIR | C.R. Bard, Inc. | 1990-09-27 |
| K902355 | MCR4000 & MCR4000F CARDIOTOMY RESERVOIR | Medtronic Vascular | 1990-08-23 |
| K874924 | CAP-35 AND CAP35 F | Gish Biomedical, Inc. | 1988-01-19 |
Legacy Summary#
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FDA Review#
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