K904944 is an FDA 510(k) clearance for the TRANSLUMINAL ENDARTERECTOMY DEVICE. This device is classified as a Stripper, Artery, Intraluminal (Class II - Special Controls, product code DWX).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on December 17, 1990, 46 days after receiving the submission on November 1, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K904944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1990 |
| Decision Date | December 17, 1990 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DWX — Stripper, Artery, Intraluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4875 |