The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Regalia Xs 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000.
| Device ID | K083146 |
| 510k Number | K083146 |
| Device Name: | ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000 |
| 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 | 2008-10-23 |
| Decision Date | 2008-11-21 |
| Summary: | summary |