510(k) K171613

ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip by Asahi Intecc Co., Ltd. — Product Code MOF

K171613 is an FDA 510(k) premarket notification submitted by Asahi Intecc Co., Ltd. for the device "ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip". The FDA issued a decision of Substantially Equivalent on Jul 1, 2017. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Asahi Intecc Co., Ltd. has 83 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 1, 2017
Date Received
Jun 1, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Wire, Catheter, Neurovasculature
Device Class
Class II
Regulation Number
870.1330
Review Panel
NE
Submission Type
510(k)