9008

• FDA 510(k) K874498 decided 11 Feb 1988 Active
• FDA GUDID UDI-DI 00763000028213 listed 15 Mar 2020 Listed

• 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.

1. 12 Feb 2009 Recall initiated FDA recalls Z-1147-2009
2. 12 Feb 2009 Recall initiated FDA recalls Z-1145-2009
3. 12 Feb 2009 Recall initiated FDA recalls Z-1141-2009
4. 12 Feb 2009 Recall initiated FDA recalls Z-1136-2009
5. 12 Feb 2009 Recall initiated FDA recalls Z-1140-2009
6. 12 Feb 2009 Recall initiated FDA recalls Z-1138-2009
7. 12 Feb 2009 Recall initiated FDA recalls Z-1130-2009
8. 12 Feb 2009 Recall initiated FDA recalls Z-1133-2009
9. 12 Feb 2009 Recall initiated FDA recalls Z-1152-2009
10. 15 Mar 2020 Listed FDA GUDID 00763000028213

21 earlier events are in the sections above.

Generic name

Catheter orifice occluder

Model / reference

9008

Primary DI / UDI-DI

00763000028213

510(k) Number

K874498 ↗

FDA product code

JXG

GMDN term

Catheter orifice occluder

Device class

Class II

Regulation number

882.5550

GUDID distribution status

In Commercial Distribution

Category: Catheter orifice occluder

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

• CODMAN® HAKIM® 823025 82-3025 by Integra LifeSciences Production Corporation
• H-H IN-LINE VALVED CATHETER 2 TYPES by Holter-Hausner Intl.
• PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR by Pudenz-Schulte Medical Research Corp.
• H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG by Holter-Hausner Intl.
• OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM by Integra Lifesciences Corp.
• CODMAN® HAKIM® 823019 82-3019 by Integra LifeSciences Production Corporation
• HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM by Codman & Shurtleff, Inc.
• ACURA ELITE GRAVITY COMPENSATING RESERVOIR by Phoenix Biomedical Corp.
• EQUI-FLOW VALVE AND SHUNT SYSTEM by Integra Neurosciences Implants S.A.
• Borvo EVAC System (Ergo); Borvo EVAC System (Classic) by Borvo Medical, Inc.

• Strata® 45808

  Class II

  FDA 510(k) K041992 Active Cleared 28 Jan 2005 GUDID on market

• StrataMR2 46955MR

  Class II

  FDA 510(k) K212641 Active Cleared 16 Sep 2021 GUDID on market

• StrataMR2 46957MR

  Class II

  FDA 510(k) K212641 Active Cleared 16 Sep 2021 GUDID on market

• Innervision 27065 D

  Class II

  FDA 510(k) K983331 Active Cleared 16 Dec 1998 GUDID on market

See all devices from Medtronic PS Medical →