AuST Steerable Sheath ADS-MD-002968
AuST Steerable Sheath ADS-MD-002968 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 00810024672660), 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 | Number00810024672660 | Date6 Aug 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK260942 | Date7 Apr 2026 | StatusActive |
Official records
- AccessGUDID record 00810024672660
- FDA 510(k) database K260942
Across registries
- FDA 510(k) K260942 decided 7 Apr 2026 Active
- FDA GUDID UDI-DI 00810024672660 listed 6 Aug 2026 Listed
Timeline
- Cleared FDA 510(k) K260942
- Listed FDA GUDID 00810024672660
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- Withdrawn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-002968
- Primary DI / UDI-DI
- 00810024672660
- 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).
- INTRODUCER, CAT. #INT-07FR. by Sorensen Research
- CANNULA INTRODUCER by Cardiovascular Research, Inc.
- Occlutech Delivery Set III 98DL009 by Oscor Inc.
- DUAL GUIDE INTRODUCER CATHETER by Cook, Inc.
- MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 by Cryocor, Inc.
- CORDIS AVANTI CATHETER SHEATH INTRODUCER by Cordis US Corp.
- PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH by TERUMO MEDICAL CORPORATION
- USCI(R) ACCESS(TM) INTRODUCER SET by C. R. Bard, Inc.
- Prelude Guide Sheath by Merit Medical Systems, Inc.
- Adelante Breezeway AB063001 by Oscor Inc.