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510(k) K161873

Pacel Flow Directed Pacing Catheter by St Jude Medical — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2016
Date Received
July 7, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Pacemaker, Temporary
Device Class
Class II
Regulation Number
870.3680
Review Panel
CV
Submission Type

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