FieldFlex Sheath FXS-MD-002000
FieldFlex Sheath FXS-MD-002000 is a vascular guide-catheter (FDA Class II; FDA product code DYB, Introducer, Catheter) made by CenterPoint Systems LLC, cleared under FDA 510(k) K261492 on 5 Jun 2026 and listed in FDA GUDID since 23 Oct 2026 (UDI-DI 00810024673148), active as of 9 Nov 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 | Number00810024673148 | Date23 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK261492 | Date5 Jun 2026 | StatusActive |
Official records
- AccessGUDID record 00810024673148
- FDA 510(k) database K261492
Across registries
- FDA 510(k) K261492 decided 5 Jun 2026 Active
- FDA GUDID UDI-DI 00810024673148 listed 23 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K261492
- Listed FDA GUDID 00810024673148
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- FieldFlex Sheath
- Generic name
- Vascular guide-catheter, single-use
- Model / reference
- FXS-MD-002000
- Primary DI / UDI-DI
- 00810024673148
- 510(k) Number
- FDA product code
- DYB
- GMDN term
- Vascular guide-catheter, single-use
- Device class
- Class II
- Regulation number
- 870.1340
- GUDID distribution status
- In Commercial Distribution
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