Submission Details
| 510(k) Number | K222837 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 20, 2022 |
| Decision Date | December 08, 2022 |
| Days to Decision | 79 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
Dec 2022
Decision
79d
Days
Class 2
Risk
About This 510(k) Submission
K222837 is an FDA 510(k) clearance for the Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on December 8, 2022, 79 days after receiving the submission on September 20, 2022. 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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