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9008

by Medtronic PS Medical 3 variants

9008 is a Class II device made by Medtronic PS Medical, cleared under FDA 510(k) K874498 on 11 Feb 1988 and listed in FDA GUDID since 23 Jun 2015 (UDI-DI 00643169010369), active as of 22 Oct 2026. 29 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

None ongoing

29 closed

Documents

510(k) K874498

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 Number00643169010369 UDI-DI Date23 Jun 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK874498 Date11 Feb 1988DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K874498 decided 11 Feb 1988 Active
  • FDA GUDID UDI-DI 00643169010369 listed 23 Jun 2015 Listed

Recalls

29 recalls · FDA

  • 29 recalls, same reason

    • Terminated Z-1146-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • 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

    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

31 dated events

  1. Recall initiated FDA recalls Z-1147-2009
  2. Recall initiated FDA recalls Z-1145-2009
  3. Recall initiated FDA recalls Z-1141-2009
  4. Recall initiated FDA recalls Z-1136-2009
  5. Recall initiated FDA recalls Z-1140-2009
  6. Recall initiated FDA recalls Z-1138-2009
  7. Recall initiated FDA recalls Z-1130-2009
  8. Recall initiated FDA recalls Z-1133-2009
  9. Recall initiated FDA recalls Z-1152-2009
  10. Listed FDA GUDID 00643169010369

21 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
Catheter orifice occluder
Model / reference
9008
Primary DI / UDI-DI
00643169010369
510(k) Number
FDA product code
JXG
GMDN term
Catheter orifice occluder
Device class
Class II
Regulation number
882.5550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Catheter orifice occluder

Cleared under the same submission (K874498)

and 8 more cleared under K874498

Similar devices

Other devices filed under FDA product code JXG (Shunt, central nervous system and components).

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

See all devices from Medtronic PS Medical →

Properties

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