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510(k) K181647

Bandit guidewire by Vascular Solutions, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2018
Date Received
June 22, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

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