The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi Chikai Black, Asahi Neurovascular.
| Device ID | K141751 |
| 510k Number | K141751 |
| Device Name: | ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | ASAHI INTECC CO., LTD. 5523 RESEARCH PARK DRIVE SUITE 205 Baltimore, MD 21228 |
| Contact | Semih Oktay |
| Correspondent | Semih Oktay ASAHI INTECC CO., LTD. 5523 RESEARCH PARK DRIVE SUITE 205 Baltimore, MD 21228 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-30 |
| Decision Date | 2015-01-30 |
| Summary: | summary |