Submission Details
| 510(k) Number | K940824 FDA.gov |
| FDA Decision | Not Cleared PT (PT) |
| Date Received | January 06, 1994 |
| Decision Date | May 04, 1994 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Not Cleared
Traditional
K940824 - DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III (FDA 510(k) Clearance)
May 1994
Decision
118d
Days
Class 2
Risk
K940824 is an FDA 510(k) submission for the DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III. This device is classified as a Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (Class II - Special Controls, product code DYF).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Not Cleared (DENG) decision on May 4, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
Device Classification
| Product Code | DYF — Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |