K971421 is an FDA 510(k) clearance for the BARD ISOFLOW BLOOD PUMP. This device is classified as a Control, Pump Speed, Cardiopulmonary Bypass (Class II - Special Controls, product code DWA).
Submitted by C.R. Bard, Inc. (Haverhill, US). The FDA issued a Cleared decision on May 14, 1998, 393 days after receiving the submission on April 16, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4380.
| 510(k) Number | K971421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 1997 |
| Decision Date | May 14, 1998 |
| Days to Decision | 393 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWA — Control, Pump Speed, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4380 |