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AuST Steerable Sheath ADS-MD-002961

by CenterPoint Systems LLC

AuST Steerable Sheath ADS-MD-002961 is a vascular guide-catheter (FDA Class II) made by CenterPoint Systems LLC, cleared under FDA 510(k) K260942 on 7 Apr 2026 and listed in FDA GUDID since 6 Aug 2026 (UDI-DI 00810024672592), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K260942

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810024672592 UDI-DI Date6 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK260942 Date7 Apr 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K260942 decided 7 Apr 2026 Active
  • FDA GUDID UDI-DI 00810024672592 listed 6 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K260942
  2. Listed FDA GUDID 00810024672592

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AuST Steerable Sheath
Generic name
Vascular guide-catheter, single-use
Model / reference
ADS-MD-002961
Primary DI / UDI-DI
00810024672592
510(k) Number
FDA product code
DYB, DRA
GMDN term
Vascular guide-catheter, single-use
Device class
Class II
Regulation number
870.1340, 870.1280
GUDID distribution status
In Commercial Distribution
Size
Catheter Working Length — 74 Centimeter

Related devices

Cleared under the same submission (K260942)

and 8 more cleared under K260942

Similar devices

Other devices filed under FDA product code DYB (Introducer, Catheter).

Other devices from CenterPoint Systems LLC

See all devices from CenterPoint Systems LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)