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510(k) K253652

Genie MAX Large Bore Introducer Sheath by Cultiv8 1, LLC — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2026
Date Received
November 20, 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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