Passio Adapter Kit PAS-06
Passio Adapter Kit PAS-06 is a pleural/peritoneal drainage catheterization kit (FDA Class II; FDA product code DWM, Apparatus, Suction, Patient Care) made by Bearpac Medical, LLC, cleared under FDA 510(k) K201404 on 20 Nov 2020 and listed in FDA GUDID since 11 Aug 2023 (UDI-DI 00860099001353), 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 | Number00860099001353 | Date11 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201404 | Date20 Nov 2020 | StatusActive |
Official records
- AccessGUDID record 00860099001353
- FDA 510(k) database K201404
Across registries
- FDA 510(k) K201404 decided 20 Nov 2020 Active
- FDA GUDID UDI-DI 00860099001353 listed 11 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K201404
- Listed FDA GUDID 00860099001353
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Passio Adapter Kit
- Generic name
- Pleural/peritoneal drainage catheterization kit, non-medicated
- Model / reference
- PAS-06
- Primary DI / UDI-DI
- 00860099001353
- 510(k) Number
- FDA product code
- DWM
- GMDN term
- Pleural/peritoneal drainage catheterization kit, non-medicated
- Device class
- Class II
- Regulation number
- 870.5050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Pleural/peritoneal drainage catheterization kit.