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 Blue 180cm Asahi Ptca Guide Wire Asahi Sion Blue 3300cm Asahi Ptca Guide Wire Asahi Sio.
| Device ID | K122468 |
| 510k Number | K122468 |
| Device Name: | ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO |
| 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 | 2012-08-13 |
| Decision Date | 2013-03-08 |
| Summary: | summary |