K053268 is an FDA 510(k) clearance for the PVS 2000 SYNCHRO2 GUIDEWIRE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Boston Scientific - Precision Vascular (West Valley City, US). The FDA issued a Cleared decision on March 13, 2006, 110 days after receiving the submission on November 23, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K053268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2005 |
| Decision Date | March 13, 2006 |
| Days to Decision | 110 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 |