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510(k) K091582

GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 by Medtronic Vascular — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2009
Date Received
June 2, 2009
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

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