AuST Steerable Sheath
K-Number: K260942 · 2026-04-07
ApplicantCenterPoint Systems, LLC
Decision Date2026-04-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
AuST Steerable Sheath is a medical device manufactured by CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2026-04-07 under approval number K260942. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AuST Steerable Sheath?
AuST Steerable Sheath is a medical device that received FDA 510(k) clearance on 2026-04-07. It is manufactured by CenterPoint Systems, LLC. The 510(k) number is K260942.
When was AuST Steerable Sheath approved by the FDA?
AuST Steerable Sheath received FDA 510(k) clearance on 2026-04-07, under approval number K260942.
What company makes AuST Steerable Sheath?
AuST Steerable Sheath is manufactured by CenterPoint Systems, LLC.
What is the FDA product code for AuST Steerable Sheath?
The FDA product code for AuST Steerable Sheath is DYB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.