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510(k) K193119

Twin-Pass Dual Access Catheter by Vascular Solutions, LLC — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2020
Date Received
November 12, 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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