The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Chikai Neurovascular Guide Wire (round Curve).
| Device ID | K160659 |
| 510k Number | K160659 |
| Device Name: | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | ASAHI INTECC CO., LTD. 2055 RED HILL AVENUE, SUITE 210 Santa Ana, CA 92705 |
| Contact | Carroll Councilman |
| Correspondent | Candace Cederman CARDIOMED DEVICE CONSULTANTS, LLC 5523 RESEARCH PARK DRIVE, SUITE 205 Baltimore, MD 21228 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-08 |
| Decision Date | 2016-04-07 |
| Summary: | summary |