K982363 is an FDA 510(k) clearance for the OASIS THROMBECTOMY CATHETER SYSTEM. This device is classified as a Catheter, Peripheral, Atherectomy (Class II - Special Controls, product code MCW).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on February 23, 1999, 232 days after receiving the submission on July 6, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K982363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1998 |
| Decision Date | February 23, 1999 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MCW — Catheter, Peripheral, Atherectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4875 |