FDA.reportPublic FDA data

AuST Steerable Sheath

Primary DI
00810024672912
Brand
AuST Steerable Sheath
Company
CENTERPOINT SYSTEMS LLC
Model
ADS-MD-003078
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.
Published
2026-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRACatheter, Steerable
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRACatheter, SteerableCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260942000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260942000AuST Steerable SheathCenterPoint Systems, LLC2026-04-07DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810024672912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810024672912008100246729128100246729120810024672912

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA 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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
117126091
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810024672011CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-42DS5D200-422026-08-04
00810024672028CPS Locator 3D Plus, Large Delivery CatheterDS5D300-42DS5D300-422026-08-04
00810024672035CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-42DS5D400-422026-08-04
00810024672042CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-45DS5D200-452026-08-04
00810024672059CPS Locator 3D Plus, Large Delivery CatheterDS5D300-45DS5D300-452026-08-04
00810024672066CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-45DS5D400-452026-08-04
00810024672196CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-48DS5D200-482026-08-04
00810024672202CPS Locator 3D Plus, Large Delivery CatheterDS5D300-48DS5D300-482026-08-04
00810024672219CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-48DS5D400-482026-08-04
00810024672554AuST Steerable SheathADS-MD-0029572026-08-06
00810024672561AuST Steerable SheathADS-MD-0029582026-08-06
00810024672578AuST Steerable SheathADS-MD-0029592026-08-06
00810024672585AuST Steerable SheathADS-MD-0029602026-08-06
00810024672592AuST Steerable SheathADS-MD-0029612026-08-06
00810024672608AuST Steerable SheathADS-MD-0029622026-08-06
00810024672615AuST Steerable SheathADS-MD-0029632026-08-06
00810024672622AuST Steerable SheathADS-MD-0029642026-08-06
00810024672639AuST Steerable SheathADS-MD-0029652026-08-06
00810024672646AuST Steerable SheathADS-MD-0029662026-08-06
00810024672653AuST Steerable SheathADS-MD-0029672026-08-06

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Primary DI, Brand, Company table
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