The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Ptca Guide Wire, Fielder J, Model Agp140000j, Agp140300j.
| Device ID | K062186 |
| 510k Number | K062186 |
| Device Name: | ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J |
| Classification | Wire, Guide, Catheter |
| Applicant | ASAHI INTECC CO., LTD. 1301 DOVE STREET, SUITE #350 Newport Beach, CA 92660 |
| Contact | Yoshi Terai |
| Correspondent | Yoshi Terai ASAHI INTECC CO., LTD. 1301 DOVE STREET, SUITE #350 Newport Beach, CA 92660 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-31 |
| Decision Date | 2006-11-09 |
| Summary: | summary |