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510(k) K190884

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool by Datascope Corp. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2019
Date Received
April 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

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