K950586 is an FDA 510(k) clearance for the AVD INTIMAX THROMBECTOMY CATHETER. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on May 15, 1995, 95 days after receiving the submission on February 9, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K950586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1995 |
| Decision Date | May 15, 1995 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXE — Catheter, Embolectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |