Submission Details
| 510(k) Number | K962726 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 15, 1996 |
| Decision Date | October 30, 1996 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
BARD QUANTUM CVR
Oct 1996
Decision
107d
Days
Class 2
Risk
About This 510(k) Submission
K962726 is an FDA 510(k) clearance for the BARD QUANTUM CVR, a Defoamer, Cardiopulmonary Bypass (Class II — Special Controls, product code DTP), submitted by C.R. Bard, Inc. (Haverhill, US). The FDA issued a Cleared decision on October 30, 1996, 107 days after receiving the submission on July 15, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4230.
Device Classification
| Product Code | DTP — Defoamer, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4230 |
Manufacturer
Similar Devices — DTP Defoamer, Cardiopulmonary Bypass
All 33
K101186 · Medtronic Perfusion Systems
· Sep 2010
K082412 · Mapquet Cardiopulmonary AG
· Nov 2008
K004046 · Cobe Cardiovascular, Inc.
· Apr 2001
K002591 · Cobe Cardiovascular, Inc.
· Sep 2000
K990514 · C.R. Bard, Inc.
· Mar 1999
K984322 · Dideco S.P.A.
· Mar 1999
More from C.R. Bard, Inc.
View all
K251864
· KOD · Feb 2026
K251186
· LDF · May 2025
K241334
· LDF · Jan 2025
K230356
· QEW · Mar 2023
K223177
· LIT · Jan 2023