Inlet Filter - Regular VWSP-460
by Inovytec Medical Solutions Ltd
Inlet Filter - Regular VWSP-460 is a gas sampling line filter (FDA Class II; FDA product code CBK, Ventilator, Continuous, Facility Use) made by Inovytec Medical Solutions Ltd, cleared under FDA 510(k) K202970 on 29 Jan 2021 and listed in FDA GUDID since 11 Jan 2023 (UDI-DI 07290017096964), 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 | Number07290017096964 | Date11 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202970 | Date29 Jan 2021 | StatusActive |
Official records
- AccessGUDID record 07290017096964
- FDA 510(k) database K202970
Across registries
- FDA 510(k) K202970 decided 29 Jan 2021 Active
- FDA GUDID UDI-DI 07290017096964 listed 11 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K202970
- Listed FDA GUDID 07290017096964
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Inlet Filter - Regular
- Generic name
- Gas sampling line filter, single-use
- Model / reference
- VWSP-460
- Primary DI / UDI-DI
- 07290017096964
- 510(k) Number
- FDA product code
- CBK
- GMDN term
- Gas sampling line filter, single-use
- Device class
- Class II
- Regulation number
- 868.5895
- GUDID distribution status
- In Commercial Distribution
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