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510(k) K202049

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter by Applied Medical Resources Corporation — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2021
Date Received
July 24, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

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