K854431 is an FDA 510(k) clearance for the MEADOX MEDICALS INC. GRAFT SIZER. This device is classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II - Special Controls, product code DSY).
Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on May 7, 1986, 183 days after receiving the submission on November 5, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K854431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1985 |
| Decision Date | May 07, 1986 |
| Days to Decision | 183 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 |