Submission Details
| 510(k) Number | K133566 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 20, 2013 |
| Decision Date | December 20, 2013 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
Dec 2013
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K133566 is an FDA 510(k) clearance for the ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on December 20, 2013, 30 days after receiving the submission on November 20, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.
Device Classification
| Product Code | MCW — Catheter, Peripheral, Atherectomy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4875 |
Manufacturer
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