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510(k) K183305

Crossing Support Catheter by Tractus Vascular, LLC — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2019
Date Received
November 28, 2018
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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