K081337 is an FDA 510(k) clearance for the APPROACH CTO WIRE GUIDE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on August 8, 2008, 87 days after receiving the submission on May 13, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K081337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2008 |
| Decision Date | August 08, 2008 |
| Days to Decision | 87 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 |