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510(k) K250751

DualView Catheter by Terumo Corporation — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2025
Date Received
March 12, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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