Class Class II
AuST Steerable Sheath (K251051)
Description
AuST Steerable Sheath by CenterPoint Systems, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251051
Clearance Date2025-04-30
Clearance TypeSpecial
Product CodeDYB
Regulation Number870.1340
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251051
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. AuST Steerable Sheath (K251051) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026 |
Trace the full predicate network for K251051
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.