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/productcode/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](/device/K101186.md) | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG | Medtronic Perfusion Systems | Sep 3, 2010 | SESE |
| [K082412](/device/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](/device/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](/device/K002591.md) | COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | Sep 13, 2000 | SESE |
| [K990514](/device/K990514.md) | MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR | C.R. Bard, Inc. | Mar 9, 1999 | SESE |
| [K984322](/device/K984322.md) | DIDECO D920, LILLIPUT 1 TWIN RESERVOIR | Dideco S.P.A. | Mar 2, 1999 | SESE |
| [K962726](/device/K962726.md) | BARD QUANTUM CVR | C.R. Bard, Inc. | Oct 30, 1996 | SESE |
| [K941654](/device/K941654.md) | SARNS FILTERED VENOUS RESERVIOR MODIFICATION | 3M Health Care, Sarns | Jul 26, 1994 | SESE |
| [K933496](/device/K933496.md) | MAXIMA FILTERED HARDSHELL RESERVIOR | Medtronic Vascular | Oct 15, 1993 | SESE |
| [K912915](/device/K912915.md) | SARNS NON-FILTERED VENOUS RESERVOIR | 3M Health Care, Ltd. | Sep 25, 1991 | SESE |
| [K911789](/device/K911789.md) | MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT | Medtronic Vascular | Aug 20, 1991 | SESE |
| [K910568](/device/K910568.md) | MODEL 5866-46 SLEEVE KIT | Medtronic Vascular | Apr 9, 1991 | SESE |
| [K902437](/device/K902437.md) | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | Cobe Laboratories, Inc. | Dec 17, 1990 | SESE |
| [K902856](/device/K902856.md) | BARD FILTERED CARDIOTOMY RESERVOIR | C.R. Bard, Inc. | Sep 27, 1990 | SESE |
| [K902355](/device/K902355.md) | MCR4000 & MCR4000F CARDIOTOMY RESERVOIR | Medtronic Vascular | Aug 23, 1990 | SESE |
| [K874924](/device/K874924.md) | CAP-35 AND CAP35 F | Gish Biomedical, Inc. | Jan 19, 1988 | SESE |
| [K872167](/device/K872167.md) | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | American Bentley | Sep 1, 1987 | SESE |
| [K870792](/device/K870792.md) | THORASTAT ATR-XXXX | Gish Biomedical, Inc. | Apr 28, 1987 | SESE |
| [K860775](/device/K860775.md) | MEDIASTINAL AUTOTRANSFUSION SYSTEM | Cardio Metrics, Inc. | May 28, 1986 | SESE |
| [K860702](/device/K860702.md) | SARNS FILTERED CARDIOTOMY RESERVOIR | 3M Health Care, Sarns | May 28, 1986 | SESE |

## Top Applicants

- Medtronic Vascular — 4 clearances
- Scimed Life Systems, Inc. — 4 clearances
- Shiley, Inc. — 4 clearances
- C.R. Bard, Inc. — 3 clearances
- Gish Biomedical, Inc. — 3 clearances

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**Source:** [https://fda.innolitics.com/productcode/DTP](https://fda.innolitics.com/productcode/DTP)

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