K940816 is an FDA 510(k) clearance for the BARD(R) EXPANDED PTFE VASCULAR GRAFT. This device is classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II - Special Controls, product code DSY).
Submitted by C.R. Bard, Inc. (Woburn, US). The FDA issued a Cleared decision on June 2, 1994, 100 days after receiving the submission on February 22, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K940816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | February 22, 1994 |
| Decision Date | June 02, 1994 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |