K152275 is an FDA 510(k) clearance for the Pantheris System. This device is classified as a Catheter, Peripheral, Atherectomy (Class II - Special Controls, product code MCW).
Submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on October 14, 2015, 63 days after receiving the submission on August 12, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K152275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2015 |
| Decision Date | October 14, 2015 |
| Days to Decision | 63 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 |