AuST Steerable Sheath

FDA UDI

Class II (US FDA UDI)

by CenterPoint Systems LLC

Identity

Trade Name: AuST Steerable Sheath FDA UDI
Generic Name: Vascular guide-catheter, single-use FDA UDI
Device Name: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements. FDA UDI
Model / Reference: M85-MD-001465 FDA UDI
Description: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810024670901 FDA UDI
510(k) Number: K240829 FDA UDI
FDA Product Code: DYB FDA UDI
GMDN Term: Vascular guide-catheter, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vascular guide-catheter, single-use

AuST Steerable Sheath by CenterPoint Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vascular guide-catheter, single-use.

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Mach1™ — Boston Scientific · Class II
SHERPA NX BALANCED — MEDTRONIC, INC. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: CenterPoint Systems LLC

Sources (1)

FDA UDI 94e44279-9bc2-4b66-a54c-07836ef01e61 34 fields · synced Jun 9, 2026