K082935 is an FDA 510(k) clearance for the VISION WIRE CORONARY GUIDEWIRE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on December 4, 2008, 64 days after receiving the submission on October 1, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K082935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2008 |
| Decision Date | December 04, 2008 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| 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 |