K993648 is an FDA 510(k) clearance for the ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER. This device is classified as a Catheter, Peripheral, Atherectomy (Class II - Special Controls, product code MCW).
Submitted by Boston Scientific Corporation Northwest Technology (Redmond, US). The FDA issued a Cleared decision on November 24, 1999, 26 days after receiving the submission on October 29, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K993648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1999 |
| Decision Date | November 24, 1999 |
| Days to Decision | 26 days |
| Submission Type | Special |
| 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 |