The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Ptca Guide Wire Asahi Gaia Next.
| Device ID | K192599 |
| 510k Number | K192599 |
| Device Name: | ASAHI PTCA Guide Wire ASAHI Gaia Next |
| Classification | Wire, Guide, Catheter |
| Applicant | Asahi Intecc Co., Ltd. 3-100 Akatsuki-cho Seto, JP 489-0071 |
| Contact | Yasuyuki Kawahara |
| Correspondent | Cynthia Valenzuela Asahi Intecc USA, Inc. 3002 Dow Ave, Suite 212 Tustin, CA 92780 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-20 |
| Decision Date | 2020-01-02 |