The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Astato 30 Peripheral Guide Wire, Models - Pagh18m071, Pagh18m371.
| Device ID | K071721 |
| 510k Number | K071721 |
| Device Name: | ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371 |
| Classification | Wire, Guide, Catheter |
| Applicant | ASAHI INTECC CO., LTD. 2500 RED HILL AVE, SUITE 210 Santa Ana, CA 92705 |
| Contact | Yoshi Terai |
| Correspondent | Yoshi Terai ASAHI INTECC CO., LTD. 2500 RED HILL AVE, 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 | 2007-06-25 |
| Decision Date | 2007-07-13 |
| Summary: | summary |