K944844 is an FDA 510(k) clearance for the BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT. This device is classified as a Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (Class II - Special Controls, product code DYF).
Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on March 31, 1995, 182 days after receiving the submission on September 30, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K944844 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | September 30, 1994 |
| Decision Date | March 31, 1995 |
| Days to Decision | 182 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 |