K760087 is an FDA 510(k) clearance for the TAPE, VASCULAR, 1/4 DACRON. This device is classified as a Instruments, Surgical, Cardiovascular (Class I - General Controls, product code DWS).
Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1976, 29 days after receiving the submission on June 21, 1976.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500.
| 510(k) Number | K760087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1976 |
| Decision Date | July 20, 1976 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DWS — Instruments, Surgical, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4500 |