N/A 42314

by Medtronic PS Medical

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00763000028015 UDI-DI	Date16 Jan 2020Listed	StatusListed GUDID: in commercial distribution

Recalls

2 recalls · 1 ongoing · FDA

- Ongoing Z-1117-2021 FDA Class II initiated 11 Jan 2021
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
- Terminated Z-0397-2014 FDA Class II initiated 18 Nov 2013
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.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Cerebrospinal fluid shunt valve
Model / Reference: 42314

Primary DI / UDI-DI: 00763000028015
510(k) Number: K841442
FDA Product Code: JXG
GMDN Term: Cerebrospinal fluid shunt valve

Device Class: Class II
Regulation Number: 882.5550
GUDID distribution status: In Commercial Distribution

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Properties

Sterile
Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (9)

Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No