K111395 is an FDA 510(k) clearance for the PRIMEWIRE PRESTIGE PLUS. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on August 1, 2011, 74 days after receiving the submission on May 19, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K111395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2011 |
| Decision Date | August 01, 2011 |
| Days to Decision | 74 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |