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510(k) K160084

Swan Ganz Catheters by Edwards Lifesciences, LLC — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2016
Date Received
January 15, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type

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