K060745 is an FDA 510(k) clearance for the ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Asahi Intecc Co., Ltd. (Newport Beach, US). The FDA issued a Cleared decision on June 23, 2006, 95 days after receiving the submission on March 20, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K060745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2006 |
| Decision Date | June 23, 2006 |
| Days to Decision | 95 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |