The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Sion Ptca Guide Wire Model Ahw14r001s & Ahw14r301s.
| Device ID | K100578 |
| 510k Number | K100578 |
| Device Name: | ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S |
| 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 | 2010-03-01 |
| Decision Date | 2010-09-22 |
| Summary: | summary |