K072431 is an FDA 510(k) clearance for the ASAHI PTCA GUIDE WIRE, X-TREME. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Asahi Intecc Co., Ltd. (Santa Ana, US). The FDA issued a Cleared decision on September 26, 2007, 28 days after receiving the submission on August 29, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K072431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2007 |
| Decision Date | September 26, 2007 |
| Days to Decision | 28 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 |