The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Ptca Guide Wires, Asahi Corsair Microcatheter, Asahi Corsair Pro Microcatheter.
| Device ID | K171933 |
| 510k Number | K171933 |
| Device Name: | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter |
| Classification | Wire, Guide, Catheter |
| Applicant | Asahi Intecc Co., Ltd. 1703 Wakita-cho, Moriyama-Ku Nagoya, JP 463-0024 |
| Contact | Yasuyuki Kawahara |
| Correspondent | Candace Cederman Cardiomed Device Consultants, LLC 3168 Braverton Street, Suite 200 Edgewater, MD 21037 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-28 |
| Decision Date | 2018-02-12 |
| Summary: | summary |