Product code DTP— Cardiovascular
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
- Classification name
- Defoamer, Cardiopulmonary Bypass
- Device class
- Class 2
- Regulation
- 21 CFR 870.4230
- Advisory panel
- Cardiovascular
- Total cleared
- 34
- First cleared
- Most recent
Market context for product code DTP
FDA has cleared devices under product code DTP between 1980 and 2010, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2010
- 2008
- 2001
- 2000
- 1999
- 1996
- 1994
- 1993
- 1991
- 1990
- 1988
- 1987
- 1986
- 1985
- 1984
Top applicants under product code DTP
Recent clearances under product code DTP
- K101186 — AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
- K082412 — VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160
- K004046 — COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
- K002591 — COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
- K990514 — MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
- K984322 — DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
- K962726 — BARD QUANTUM CVR
- K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION
- K933496 — MAXIMA FILTERED HARDSHELL RESERVIOR
- K912915 — SARNS NON-FILTERED VENOUS RESERVOIR
- K911789 — MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT
- K910568 — MODEL 5866-46 SLEEVE KIT
- K902437 — COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
- K902856 — BARD FILTERED CARDIOTOMY RESERVOIR
- K902355 — MCR4000 & MCR4000F CARDIOTOMY RESERVOIR
- K874924 — CAP-35 AND CAP35 F
- K872167 — CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500
- K870792 — THORASTAT ATR-XXXX
- K860702 — SARNS FILTERED CARDIOTOMY RESERVOIR
- K860775 — MEDIASTINAL AUTOTRANSFUSION SYSTEM
- K855049 — MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
- K853503 — SHILEY 3L CARDIOTOMY RESERVOIR
- K851004 — CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX
- K844803 — POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE
- K842373 — VENOUS RESERVOIR-BMR-1500-HARD SHELL
- K840610 — SCIMED MODEL SC4000
- K834041 — CARDIOTOMY RESERVOIR SC3500F
- K832811 — SHILEY 3L CARDF PLUS
- K830727 — CARDIOTOMY RESERVOIR-FILTERED & NON
- K823731 — CARDF
- K821538 — CAPIOX CR-CARDIOTOMY RESERVOIR
- K820954 — SCIMED MODEL SC 3000
- K801360 — CARDIOTOMY RESERVOIR WITH FILTER
- K801375 — SHILEY CARDIOTOMY RESERVOIR W/FILTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.