DTP · Defoamer, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4230 · Class 2
Overview
| Product Code | DTP |
|---|---|
| Device Name | Defoamer, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4230 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG | Medtronic Perfusion Systems | Sep 3, 2010 | SESE |
| K082412 | 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 | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | Apr 26, 2001 | SESE |
| K002591 | COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | Sep 13, 2000 | SESE |
| K990514 | MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR | C.R. Bard, Inc. | Mar 9, 1999 | SESE |
| K984322 | DIDECO D920, LILLIPUT 1 TWIN RESERVOIR | Dideco S.P.A. | Mar 2, 1999 | SESE |
| K962726 | BARD QUANTUM CVR | C.R. Bard, Inc. | Oct 30, 1996 | SESE |
| K941654 | SARNS FILTERED VENOUS RESERVIOR MODIFICATION | 3M Health Care, Sarns | Jul 26, 1994 | SESE |
| K933496 | MAXIMA FILTERED HARDSHELL RESERVIOR | Medtronic Vascular | Oct 15, 1993 | SESE |
| K912915 | SARNS NON-FILTERED VENOUS RESERVOIR | 3M Health Care, Ltd. | Sep 25, 1991 | SESE |
| K911789 | MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT | Medtronic Vascular | Aug 20, 1991 | SESE |
| K910568 | MODEL 5866-46 SLEEVE KIT | Medtronic Vascular | Apr 9, 1991 | SESE |
| K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | Cobe Laboratories, Inc. | Dec 17, 1990 | SESE |
| K902856 | BARD FILTERED CARDIOTOMY RESERVOIR | C.R. Bard, Inc. | Sep 27, 1990 | SESE |
| K902355 | MCR4000 & MCR4000F CARDIOTOMY RESERVOIR | Medtronic Vascular | Aug 23, 1990 | SESE |
| K874924 | CAP-35 AND CAP35 F | Gish Biomedical, Inc. | Jan 19, 1988 | SESE |
| K872167 | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | American Bentley | Sep 1, 1987 | SESE |
| K870792 | THORASTAT ATR-XXXX | Gish Biomedical, Inc. | Apr 28, 1987 | SESE |
| K860775 | MEDIASTINAL AUTOTRANSFUSION SYSTEM | Cardio Metrics, Inc. | May 28, 1986 | SESE |
| K860702 | 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
