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46141

by Medtronic PS Medical

46141 is a Class II device made by Medtronic PS Medical, cleared under FDA 510(k) K984053 on 4 Feb 1999 and listed in FDA GUDID since 26 Feb 2024 (UDI-DI 20763000467399), active as of 23 Oct 2026. 6 FDA recalls are linked to it.

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) K984053

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20763000467399 UDI-DI Date26 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK984053 Date4 Feb 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K984053 decided 4 Feb 1999 Active
  • FDA GUDID UDI-DI 20763000467399 listed 26 Feb 2024 Listed

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2412-2023 FDA Class II initiated 28 Jun 2023

    Product labeling contains incorrect expiration date

  • 5 recalls, same reason

    • Terminated Z-1920-2014 FDA Class I initiated 9 Jun 2014
    • Terminated Z-1923-2014 FDA Class I initiated 9 Jun 2014
    • Terminated Z-1921-2014 FDA Class I initiated 9 Jun 2014
    • Terminated Z-1922-2014 FDA Class I initiated 9 Jun 2014
    • Terminated Z-1924-2014 FDA Class I initiated 9 Jun 2014

    Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.

Timeline

8 dated events

  1. Cleared FDA 510(k) K984053
  2. Recall initiated FDA recalls Z-1920-2014
  3. Recall initiated FDA recalls Z-1923-2014
  4. Recall initiated FDA recalls Z-1921-2014
  5. Recall initiated FDA recalls Z-1922-2014
  6. Recall initiated FDA recalls Z-1924-2014
  7. Recall initiated FDA recalls Z-2412-2023
  8. Listed FDA GUDID 20763000467399

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Ventricular cerebrospinal fluid drainage catheterization kit
Model / reference
46141
Primary DI / UDI-DI
20763000467399
510(k) Number
FDA product code
GWN, GWM, JXG
GMDN term
Ventricular cerebrospinal fluid drainage catheterization kit
Device class
Class II
Regulation number
882.1460, 882.1620, 882.5550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ventricular cerebrospinal fluid drainage catheterization kit

Cleared under the same submission (K984053)

and 8 more cleared under K984053

Similar devices in this category

Other devices filed under Ventricular cerebrospinal fluid drainage catheterization kit.

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See all devices from Medtronic PS Medical →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)