Atlas FDA

DTP

34 FDA 510(k) clearances · Product code

84 daysmedian time to decision
128 days90th percentile
34clearances measured

FDA profile

Official device name
Defoamer, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4230
Medical specialty
Cardiovascular
Flags
Life-sustaining
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RecordFirmDate
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG (K101186)Medtronic Perfusion Systems2010-09-03
VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 (K082412)Mapquet Cardiopulmonary AG2008-11-10
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K004046)Cobe Cardiovascular, Inc.2001-04-26
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K002591)Cobe Cardiovascular, Inc.2000-09-13
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR (K990514)C.R. Bard, Inc.1999-03-09
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR (K984322)Dideco S.P.A.1999-03-02
BARD QUANTUM CVR (K962726)C.R. Bard, Inc.1996-10-30
SARNS FILTERED VENOUS RESERVIOR MODIFICATION (K941654)3M Health Care, Sarns1994-07-26
MAXIMA FILTERED HARDSHELL RESERVIOR (K933496)Medtronic Vascular1993-10-15
SARNS NON-FILTERED VENOUS RESERVOIR (K912915)3M Health Care, Ltd.1991-09-25
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT (K911789)Medtronic Vascular1991-08-20
MODEL 5866-46 SLEEVE KIT (K910568)Medtronic Vascular1991-04-09
COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER (K902437)Cobe Laboratories, Inc.1990-12-17
BARD FILTERED CARDIOTOMY RESERVOIR (K902856)C.R. Bard, Inc.1990-09-27
MCR4000 & MCR4000F CARDIOTOMY RESERVOIR (K902355)Medtronic Vascular1990-08-23
CAP-35 AND CAP35 F (K874924)Gish Biomedical, Inc.1988-01-19
CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 (K872167)American Bentley1987-09-01
THORASTAT ATR-XXXX (K870792)Gish Biomedical, Inc.1987-04-28
SARNS FILTERED CARDIOTOMY RESERVOIR (K860702)3M Health Care, Sarns1986-05-28
MEDIASTINAL AUTOTRANSFUSION SYSTEM (K860775)Cardio Metrics, Inc.1986-05-28
MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR (K855049)Scimed Life Systems, Inc.1986-02-26
SHILEY 3L CARDIOTOMY RESERVOIR (K853503)Shiley, Inc.1985-11-14
CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX (K851004)Gish Biomedical, Inc.1985-05-16
POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE (K844803)Electromedics, Inc.1985-04-29
VENOUS RESERVOIR-BMR-1500-HARD SHELL (K842373)American Bentley1984-12-27
SCIMED MODEL SC4000 (K840610)Scimed Life Systems, Inc.1984-04-24
CARDIOTOMY RESERVOIR SC3500F (K834041)Scimed Life Systems, Inc.1984-01-30
SHILEY 3L CARDF PLUS (K832811)Shiley, Inc.1983-09-20
CARDIOTOMY RESERVOIR-FILTERED & NON (K830727)Electromics, Inc.1983-04-05
CARDF (K823731)Shiley, Inc.1983-01-05
CAPIOX CR-CARDIOTOMY RESERVOIR (K821538)Terumo Medical Corp.1982-08-06
SCIMED MODEL SC 3000 (K820954)Scimed Life Systems, Inc.1982-05-24
CARDIOTOMY RESERVOIR WITH FILTER (K801360)Travenol Laboratories, S.A.1980-07-14
SHILEY CARDIOTOMY RESERVOIR W/FILTER (K801375)Shiley, Inc.1980-07-14

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Every clearance here is in the API, with alerts when new ones post.