The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Crosslead Peripheral Guide Wire.
| Device ID | K213315 |
| 510k Number | K213315 |
| Device Name: | CROSSLEAD Peripheral Guide Wire |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-04 |
| Decision Date | 2022-07-01 |