The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Ptca Guide Wire.
Device ID | K070945 |
510k Number | K070945 |
Device Name: | ASAHI PTCA GUIDE WIRE |
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 | 2007-04-04 |
Decision Date | 2008-01-09 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ASAHI PTCA GUIDE WIRE 78248368 2844884 Dead/Cancelled |
Asahi Intecc Co., Ltd. 2003-05-12 |