Ballast 088 Long Sheath BALLAST105
Ballast 088 Long Sheath BALLAST105 is a Class II device made by Balt USA LLC, cleared under FDA 510(k) K182918 on 21 Mar 2019 and listed in FDA GUDID since 14 Aug 2024 (UDI-DI 00840303712817), active as of 23 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 | Number00840303712817 | Date14 Aug 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182918 | Date21 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 00840303712817
- FDA 510(k) database K182918
Across registries
- FDA 510(k) K182918 decided 21 Mar 2019 Active
- FDA GUDID UDI-DI 00840303712817 listed 14 Aug 2024 Listed
Timeline
- Cleared FDA 510(k) K182918
- Listed FDA GUDID 00840303712817
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ballast 088 Long Sheath
- Generic name
- Vascular guide-catheter, single-use
- Model / Ref / Catalog
- BALLAST105
- Primary DI / UDI-DI
- 00840303712817
- 510(k) Number
- FDA product code
- DQY
- GMDN term
- Vascular guide-catheter, single-use
- Device class
- Class II
- Regulation number
- 870.1250
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Working Length — 105 CentimeterCatheter Inner Diameter — 0.088 Inch
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