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510(k) K122590

RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE by Terumo Medical Corporation — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2013
Date Received
August 24, 2012
Clearance Type
Special
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

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