K954582 is an FDA 510(k) clearance for the BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION). 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. (Haverhill, US). The FDA issued a Cleared decision on December 7, 1995, 91 days after receiving the submission on September 7, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K954582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | September 07, 1995 |
| Decision Date | December 07, 1995 |
| Days to Decision | 91 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 |