AuST Steerable Sheath ADS-MD-002987
AuST Steerable Sheath ADS-MD-002987 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 00810024672851), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00810024672851 | Date6 Aug 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK260942 | Date7 Apr 2026 | StatusActive |
Official records
- AccessGUDID record 00810024672851
- FDA 510(k) database K260942
Across registries
- FDA 510(k) K260942 decided 7 Apr 2026 Active
- FDA GUDID UDI-DI 00810024672851 listed 6 Aug 2026 Listed
Timeline
- Cleared FDA 510(k) K260942
- Listed FDA GUDID 00810024672851
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AuST Steerable Sheath
- Generic name
- Vascular guide-catheter, single-use
- Model / reference
- ADS-MD-002987
- Primary DI / UDI-DI
- 00810024672851
- 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
Similar devices
Other devices filed under FDA product code DYB (Introducer, Catheter).
- Multiflex Steerable Sheath 17.5F by Vizaramed, Inc.
- Performer G08957 RCFW-14.0-38-30-RB by COOK INCORPORATED
- TourGuide™ Steerable Sheath TG0859017 by Oscor Inc.
- PERCUTANEOUS CATHETER INTRODUCER KIT by Intec Medical, Inc.
- SafeSheath CSG 00884450484418 CSGWORBC19M by Merit Medical Systems, Inc.
- Adelante Breezeway AB081046 by Oscor Inc.
- Check-Flo G09377 RCFW-10.0-38-80-RB by COOK INCORPORATED
- ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET by Arrow Intl., Inc.
- ARROW IPN921152 CL-07745 by TELEFLEX INCORPORATED
- VASCATH VASCULAR CATHETER PLACEMENT KIT by Titan Medical, Inc.