K220568 is an FDA 510(k) clearance for the Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series. This device is classified as a Catheter, Peripheral, Atherectomy (Class II - Special Controls, product code MCW).
Submitted by Cardiovascualr Systems, Inc. (St.Paul, US). The FDA issued a Cleared decision on April 27, 2022, 58 days after receiving the submission on February 28, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K220568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2022 |
| Decision Date | April 27, 2022 |
| Days to Decision | 58 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 |