K101985 is an FDA 510(k) clearance for the ASAHI GUIDE WIRE EXTENSION 165CM. 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 March 7, 2011, 236 days after receiving the submission on July 14, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K101985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2010 |
| Decision Date | March 07, 2011 |
| Days to Decision | 236 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 |