Product Code: DTP FDA class 2 21 CFR 870.4230

Defoamer, Cardiopulmonary Bypass

Cardiovascular

The Cardiopulmonary Bypass Defoamer is a life-sustaining cardiovascular device used within the bypass circuit or venous reservoir to remove gas bubbles from blood before it is returned to the patient, preventing air embolism during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTP and it is regulated under 21 CFR 870.4230 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DTP
Device Class: FDA class 2
Regulation Number: 870.4230
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 34 510(k) clearances via K numbers.

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