K833479 is an FDA 510(k) clearance for the WILLIAM HARVEY H-71-5-F CARDIOTOMY. This device is classified as a Reservoir, Blood, Cardiopulmonary Bypass (Class II - Special Controls, product code DTN).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1983, 70 days after receiving the submission on October 7, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K833479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1983 |
| Decision Date | December 16, 1983 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4400 |