Submission Details
| 510(k) Number | K182397 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 04, 2018 |
| Decision Date | December 13, 2018 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
Dec 2018
Decision
100d
Days
Class 2
Risk
About This 510(k) Submission
K182397 is an FDA 510(k) clearance for the Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Cardiovascular Systems, Inc. (St Paul, US). The FDA issued a Cleared decision on December 13, 2018, 100 days after receiving the submission on September 4, 2018. 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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