K143328 is an FDA 510(k) clearance for the 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip. This device is classified as a Catheter, Peripheral, Atherectomy (Class II - Special Controls, product code MCW).
Submitted by Volcano Atheromed, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 19, 2014, 29 days after receiving the submission on November 20, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K143328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2014 |
| Decision Date | December 19, 2014 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |