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510(k) K202347

UNIFUSE Infusion System with Cooper Wire by AngioDynamics, Inc. — Product Code QEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2020
Date Received
August 18, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mechanical Thrombolysis Catheter
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

To mechanically disrupt thrombus and/or debris in the peripheral vasculature.

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