The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Astato Xs 20 Peripheral Guide Wire.
| Device ID | K103057 |
| 510k Number | K103057 |
| Device Name: | ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | ASAHI INTECC CO., LTD. 2500 RED HILL SUITE 210 Santa Ana, CA 92705 |
| Contact | Yoshi Terai |
| Correspondent | Yoshi Terai ASAHI INTECC CO., LTD. 2500 RED HILL SUITE 210 Santa Ana, CA 92705 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-15 |
| Decision Date | 2010-11-19 |
| Summary: | summary |