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46022

by Medtronic PS Medical 2 variants

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K841442

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169472662 UDI-DI Date9 Jul 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK841442 Date19 Apr 1984DecidedStatusActive

Official records

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

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Ventriculoperitoneal shunt
Model / reference
46022
Primary DI / UDI-DI
00643169472662
510(k) Number
FDA product code
JXG
GMDN term
Ventriculoperitoneal shunt
Device class
Class II
Regulation number
882.5550
GUDID distribution status
In Commercial Distribution
Size
Length — 13.0 Centimeter
Length — 90.0 Centimeter
Length — 60.0 Centimeter
Length — 38.0 Centimeter

Related devices

Category: Ventriculoperitoneal shunt

Cleared under the same submission (K841442)

Show all (12)

Other devices from Medtronic PS Medical

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    Class II

  • StrataMR2 46955MR

    Class II

  • StrataMR2 46957MR

    Class II

  • Innervision 27065 D

    Class II

  • 27629

    Class II

  • Invisx™ 60110

    Class II

See all devices from Medtronic PS Medical →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number

Other properties (10)

  • Sterilise before use: No
  • 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