Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4230](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4230) → DTP — Defoamer, Cardiopulmonary Bypass # DTP · Defoamer, Cardiopulmonary Bypass _Cardiovascular · 21 CFR 870.4230 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP ## Overview - **Product Code:** DTP - **Device Name:** Defoamer, Cardiopulmonary Bypass - **Regulation:** [21 CFR 870.4230](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4230) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Life-sustaining:** yes ## Identification A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood. ## Classification Rationale Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.” ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.” ## Recent Cleared Devices (20 of 34) Showing 20 most recent of 34 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K101186](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K101186.md) | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG | Medtronic Perfusion Systems | Sep 3, 2010 | SESE | | [K082412](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K082412.md) | VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 | Mapquet Cardiopulmonary AG | Nov 10, 2008 | SESE | | [K004046](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K004046.md) | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | Apr 26, 2001 | SESE | | [K002591](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K002591.md) | COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | Sep 13, 2000 | SESE | | [K990514](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K990514.md) | MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR | C.R. Bard, Inc. | Mar 9, 1999 | SESE | | [K984322](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K984322.md) | DIDECO D920, LILLIPUT 1 TWIN RESERVOIR | Dideco S.P.A. | Mar 2, 1999 | SESE | | [K962726](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K962726.md) | BARD QUANTUM CVR | C.R. Bard, Inc. | Oct 30, 1996 | SESE | | [K941654](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K941654.md) | SARNS FILTERED VENOUS RESERVIOR MODIFICATION | 3M Health Care, Sarns | Jul 26, 1994 | SESE | | [K933496](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K933496.md) | MAXIMA FILTERED HARDSHELL RESERVIOR | Medtronic Vascular | Oct 15, 1993 | SESE | | [K912915](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K912915.md) | SARNS NON-FILTERED VENOUS RESERVOIR | 3M Health Care, Ltd. | Sep 25, 1991 | SESE | | [K911789](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K911789.md) | MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT | Medtronic Vascular | Aug 20, 1991 | SESE | | [K910568](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K910568.md) | MODEL 5866-46 SLEEVE KIT | Medtronic Vascular | Apr 9, 1991 | SESE | | [K902437](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K902437.md) | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | Cobe Laboratories, Inc. | Dec 17, 1990 | SESE | | [K902856](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K902856.md) | BARD FILTERED CARDIOTOMY RESERVOIR | C.R. Bard, Inc. | Sep 27, 1990 | SESE | | [K902355](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K902355.md) | MCR4000 & MCR4000F CARDIOTOMY RESERVOIR | Medtronic Vascular | Aug 23, 1990 | SESE | | [K874924](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K874924.md) | CAP-35 AND CAP35 F | Gish Biomedical, Inc. | Jan 19, 1988 | SESE | | [K872167](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K872167.md) | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | American Bentley | Sep 1, 1987 | SESE | | [K870792](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K870792.md) | THORASTAT ATR-XXXX | Gish Biomedical, Inc. | Apr 28, 1987 | SESE | | [K860775](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K860775.md) | MEDIASTINAL AUTOTRANSFUSION SYSTEM | Cardio Metrics, Inc. | May 28, 1986 | SESE | | [K860702](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K860702.md) | SARNS FILTERED CARDIOTOMY RESERVOIR | 3M Health Care, Sarns | May 28, 1986 | SESE | ## Top Applicants - Shiley, Inc. — 4 clearances - Scimed Life Systems, Inc. — 4 clearances - Medtronic Vascular — 4 clearances - Gish Biomedical, Inc. — 3 clearances - C.R. Bard, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com