AuST Steerable Sheath

Basic Information

• Brand Name: AuST Steerable Sheath
• Primary DI: 00810024671410
• Version / Model: 0-120H-H1765SAN0-SNSP0
• Company Name: CENTERPOINT SYSTEMS LLC
• Labeler DUNS: 117126091
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-05
• Public Version: 1
• Public Version Date: 2025-11-13
• Public Version Status: New
• Public Device Record Key: ca5cb3df-ffdf-444b-a958-d04092db1e5f

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRA	Catheter, Steerable	Cardiovascular	870.1280	2
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810024671410	GS1

Premarket Submissions

Submission Number	Supplement Number
K251051	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Catheter Inner Diameter, French Size = 12F
Device Size Text, specify			Outer Diameter, French Size = 15.9F
Catheter Working Length	65	Centimeter
Device Size Text, specify			Distal Deflection Diameter, Bidirectional = 17mm