K933498 is an FDA 510(k) clearance for the EXTERNAL VEIN STRIPPER. This device is classified as a Stripper, Artery, Intraluminal (Class II - Special Controls, product code DWX).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on March 23, 1994, 247 days after receiving the submission on July 19, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K933498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1993 |
| Decision Date | March 23, 1994 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWX — Stripper, Artery, Intraluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4875 |