DTP — Defoamer, Cardiopulmonary Bypass Class II
FDA product code DTP covers "Defoamer, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4230. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTP
- Device Class
- Class II
- Regulation Number
- 870.4230
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K101186 | medtronic perfusion systems | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDI | September 3, 2010 |
| K082412 | mapquet cardiopulmonary | VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODE | November 10, 2008 |
| K004046 | cobe cardiovascular | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED | April 26, 2001 |
| K002591 | cobe cardiovascular | COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | September 13, 2000 |
| K990514 | c.r. bard | MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR | March 9, 1999 |
| K984322 | dideco | DIDECO D920, LILLIPUT 1 TWIN RESERVOIR | March 2, 1999 |
| K962726 | c.r. bard | BARD QUANTUM CVR | October 30, 1996 |
| K941654 | 3m health care, sarns | SARNS FILTERED VENOUS RESERVIOR MODIFICATION | July 26, 1994 |
| K933496 | medtronic vascular | MAXIMA FILTERED HARDSHELL RESERVIOR | October 15, 1993 |
| K912915 | 3m health care | SARNS NON-FILTERED VENOUS RESERVOIR | September 25, 1991 |
| K911789 | medtronic vascular | MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT | August 20, 1991 |
| K910568 | medtronic vascular | MODEL 5866-46 SLEEVE KIT | April 9, 1991 |
| K902437 | cobe laboratories | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | December 17, 1990 |
| K902856 | c.r. bard | BARD FILTERED CARDIOTOMY RESERVOIR | September 27, 1990 |
| K902355 | medtronic vascular | MCR4000 & MCR4000F CARDIOTOMY RESERVOIR | August 23, 1990 |
| K874924 | gish biomedical | CAP-35 AND CAP35 F | January 19, 1988 |
| K872167 | american bentley | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | September 1, 1987 |
| K870792 | gish biomedical | THORASTAT ATR-XXXX | April 28, 1987 |
| K860775 | cardio metrics | MEDIASTINAL AUTOTRANSFUSION SYSTEM | May 28, 1986 |
| K860702 | 3m health care, sarns | SARNS FILTERED CARDIOTOMY RESERVOIR | May 28, 1986 |