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510(k) K192558

Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter by Mivi Neurovascular — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2020
Date Received
September 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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