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510(k) K131079

CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC by Creganna Medical Devices — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2013
Date Received
April 17, 2013
Clearance Type
Traditional
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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