K081021 is an FDA 510(k) clearance for the KINETIX GUIDEWIRE, PLUS GUIDEWIRE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on August 8, 2008, 120 days after receiving the submission on April 10, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K081021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2008 |
| Decision Date | August 08, 2008 |
| Days to Decision | 120 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 |