AuST CSP Introducer
K-Number: K260163 · 2026-02-19
ApplicantCenterPoint Systems, LLC
Decision Date2026-02-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
AuST CSP Introducer is a medical device manufactured by CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2026-02-19 under approval number K260163. 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 CSP Introducer?
AuST CSP Introducer is a medical device that received FDA 510(k) clearance on 2026-02-19. It is manufactured by CenterPoint Systems, LLC. The 510(k) number is K260163.
When was AuST CSP Introducer approved by the FDA?
AuST CSP Introducer received FDA 510(k) clearance on 2026-02-19, under approval number K260163.
What company makes AuST CSP Introducer?
AuST CSP Introducer is manufactured by CenterPoint Systems, LLC.
What is the FDA product code for AuST CSP Introducer?
The FDA product code for AuST CSP Introducer 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.