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510(k) K112398

TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT by Galt Medical — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2012
Date Received
August 19, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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