K923483 is an FDA 510(k) clearance for the BARD WILLIAM HARVEY AORTIC ARCH CANULAE. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on March 22, 1993, 250 days after receiving the submission on July 15, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K923483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1992 |
| Decision Date | March 22, 1993 |
| Days to Decision | 250 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4210 |