25104
by Medtronic PS Medical 3 variants
25104 is a Class II device made by Medtronic PS Medical, cleared under FDA 510(k) K792005 on 16 Jan 1980 and listed in FDA GUDID since 25 Jun 2015 (UDI-DI 00613994965813), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00613994965813 | Date25 Jun 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK792005 | Date16 Jan 1980 | StatusActive |
Official records
- AccessGUDID record 00613994965813
- FDA 510(k) database K792005
Across registries
- FDA 510(k) K792005 decided 16 Jan 1980 Active
- FDA GUDID UDI-DI 00613994965813 listed 25 Jun 2015 Listed
Recalls
-
- Terminated Z-0397-2014
Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
Timeline
- Cleared FDA 510(k) K792005
- Recall initiated FDA recalls Z-0397-2014
- Listed FDA GUDID 00613994965813
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Peritoneal/atrial cerebrospinal fluid catheter
- Model / reference
- 25104
- Primary DI / UDI-DI
- 00613994965813
- 510(k) Number
- FDA product code
- JXG
- GMDN term
- Peritoneal/atrial cerebrospinal fluid catheter
- Device class
- Class II
- Regulation number
- 882.5550
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 90.0 CentimeterOuter Diameter — 2.5 Millimeter
Similar devices in this category
Other devices filed under Peritoneal/atrial cerebrospinal fluid catheter.