The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Minamo.
Device ID | K190176 |
510k Number | K190176 |
Device Name: | MINAMO |
Classification | Wire, Guide, Catheter |
Applicant | Asahi Intecc Co., Ltd. 3-100 Akatsuki-cho Seto, JP 489-0071 |
Contact | Yasuyuki Kawahara |
Correspondent | Candace Cederman CardioMed Device Consultants, LLC 3168 Braverton Street, Suite 200 Edgewater, MD 21037 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-01 |
Decision Date | 2019-08-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MINAMO 79167844 4857400 Live/Registered |
ASAHI INTECC CO., LTD. 2015-04-16 |
MINAMO 75587558 not registered Dead/Abandoned |
KOKUYO KABUSHIKI KAISHA 1998-11-12 |