K770235 is an FDA 510(k) clearance for the DEBAKEY VASCULOUR-D PROSTHESES. This device is classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II - Special Controls, product code DSY).
Submitted by Usci, Div. C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1977, 17 days after receiving the submission on February 7, 1977.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K770235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1977 |
| Decision Date | February 24, 1977 |
| Days to Decision | 17 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 |