K984183 is an FDA 510(k) clearance for the PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451. This device is classified as a Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (Class II - Special Controls, product code DYF).
Submitted by Possis Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 1, 1999, 70 days after receiving the submission on November 23, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K984183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1998 |
| Decision Date | February 01, 1999 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYF — Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |