K802906 is an FDA 510(k) clearance for the WILLIAM HARVEY OXYGENATING GAS FILTER. This device is classified as a Accessory Equipment, Cardiopulmonary Bypass (Class I - General Controls, product code KRI).
Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on December 16, 1980, 29 days after receiving the submission on November 17, 1980.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4200.
| 510(k) Number | K802906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1980 |
| Decision Date | December 16, 1980 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KRI — Accessory Equipment, Cardiopulmonary Bypass |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4200 |