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510(k) K260942

AuST Steerable Sheath by CenterPoint Systems, LLC — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2026
Date Received
March 20, 2026
Clearance Type
Special
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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  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
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  • K252508 — Intri26 Introducer Sheath (December 17, 2025)
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