The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Pci Guide Wire Asahi Confianza Pro 8-20.
| Device ID | K211898 |
| 510k Number | K211898 |
| Device Name: | ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 |
| Classification | Wire, Guide, Catheter |
| Applicant | Asahi Intecc Co., Ltd. 3-100 Akatsuki-cho Seto, JP 489-0071 |
| Contact | Tomoya Eguchi |
| Correspondent | Cynthia Valenzuela Asahi Intecc USA, Inc. 3002 Dow Avenue, 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 | 2021-06-21 |
| Decision Date | 2021-12-08 |