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510(k) K163004

Radifocus Glidewire Advantage Track by Ashitaka Factory Of Terumo Coporation — Product Code DQX

K163004 is an FDA 510(k) premarket notification submitted by Ashitaka Factory Of Terumo Coporation for the device "Radifocus Glidewire Advantage Track". The FDA issued a decision of Substantially Equivalent on Jan 30, 2017. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 30, 2017
Date Received
Oct 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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FDA data resources