The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Ptca Guide Wire Asahi Sion 180cmj Asahi Ptca Guide Wire Asahi Sion 300cmj.
| Device ID | K122469 |
| 510k Number | K122469 |
| Device Name: | ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ |
| 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 | 2012-08-13 |
| Decision Date | 2013-03-08 |
| Summary: | summary |