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22011 M

by Medtronic PS Medical 2 variants

22011 M is a Class II device made by Medtronic PS Medical, cleared under FDA 510(k) K792007 on 16 Jan 1980 and listed in FDA GUDID since 24 Jun 2015 (UDI-DI 00643169467149), active as of 22 Oct 2026. 31 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) K792007

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169467149 UDI-DI Date24 Jun 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK792007 Date16 Jan 1980DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K792007 decided 16 Jan 1980 Active
  • FDA GUDID UDI-DI 00643169467149 listed 24 Jun 2015 Listed

Recalls

31 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.

  • 29 recalls, same reason

    • Terminated Z-1128-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1150-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1132-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1124-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1151-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1129-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1149-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1131-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1126-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1135-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1137-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1125-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1139-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1142-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1148-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1144-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1134-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1127-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1143-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1147-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1145-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1141-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1136-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1140-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1138-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1130-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1133-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1152-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1146-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009

    The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.

Timeline

33 dated events

  1. Recall initiated FDA recalls Z-1136-2009
  2. Recall initiated FDA recalls Z-1140-2009
  3. Recall initiated FDA recalls Z-1138-2009
  4. Recall initiated FDA recalls Z-1130-2009
  5. Recall initiated FDA recalls Z-1133-2009
  6. Recall initiated FDA recalls Z-1152-2009
  7. Recall initiated FDA recalls Z-1146-2009
  8. Recall initiated FDA recalls Z-0397-2014
  9. Listed FDA GUDID 00643169467149
  10. Recall initiated FDA recalls Z-1117-2021

23 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Ventriculo-peritoneal/atrial shunt
Model / reference
22011 M
Primary DI / UDI-DI
00643169467149
510(k) Number
FDA product code
JXG
GMDN term
Ventriculo-peritoneal/atrial shunt
Device class
Class II
Regulation number
882.5550
GUDID distribution status
In Commercial Distribution
Size
Length — 90.0 Centimeter
Outer Diameter — 2.1 Millimeter

Related devices

Category: Ventriculo-peritoneal/atrial shunt

Cleared under the same submission (K792007)

and 8 more cleared under K792007

Other devices from Medtronic PS Medical

  • Strata® 45808

    Class II

  • StrataMR2 46955MR

    Class II

  • StrataMR2 46957MR

    Class II

  • Innervision 27065 D

    Class II

See all devices from Medtronic PS Medical →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)