K162326 is an FDA 510(k) clearance for the Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled. 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 18, 2016, 60 days after receiving the submission on August 19, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K162326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2016 |
| Decision Date | October 18, 2016 |
| Days to Decision | 60 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 |