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510(k) K254236

Peel-Away Introducer Sheath by VascuTech Medical, LLC — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2026
Date Received
December 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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