The following data is part of a premarket notification filed by Asahi Intecc Usa, Inc. with the FDA for Asahi Treasure Floppy Peripheral Guide Wire.
| Device ID | K110553 |
| 510k Number | K110553 |
| Device Name: | ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | ASAHI INTECC USA, INC. 2500 RED HILL AVENUE SUITE 210 Santa Ana, CA 92705 |
| Contact | Yoshi Terai |
| Correspondent | Yoshi Terai ASAHI INTECC USA, INC. 2500 RED HILL AVENUE 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 | 2011-02-28 |
| Decision Date | 2011-03-18 |
| Summary: | summary |