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510(k) K152335

Export Advance Aspiration Catheter by Medtronic, Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2015
Date Received
August 19, 2015
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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