Submission Details
| 510(k) Number | K211738 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 07, 2021 |
| Decision Date | September 14, 2021 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Rotarex Atherectomy System
Sep 2021
Decision
99d
Days
Class 2
Risk
About This 510(k) Submission
K211738 is an FDA 510(k) clearance for the Rotarex Atherectomy System, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on September 14, 2021, 99 days after receiving the submission on June 7, 2021. 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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