Ps Medical Delta Csf-Flow Control Valve

• • Ongoing Z-1115-2021 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

• 3 recalls, same reason

  • Ongoing Z-0871-2021 FDA Class II ·initiated 16 Dec 2020
  • Ongoing Z-0873-2021 FDA Class II ·initiated 16 Dec 2020
  • Ongoing Z-0872-2021 FDA Class II ·initiated 16 Dec 2020

  Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction

• • Terminated Z-0398-2014 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.

510(k) Number

K902783 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• P-S Medical CSF Access Dev 15MM/25MM

  Class II

  FDA 510(k) K833822 Active Cleared 25 May 1984

• Ps Medical Ipi Vascular Access Catheter

  Class II

  FDA 510(k) K954409 Active Cleared 18 Dec 1995

• Ps Medical Catheter Placement Kit

  Class II

  FDA 510(k) K940096 Active Cleared 3 May 1994

• Csf-Cardiac/Peritoneal Catheter

  Class II

  FDA 510(k) K871752 Active Cleared 22 May 1987

• P-S Csf-Ventricular Catheter, Flanged

  Class II

  FDA 510(k) K823503 Active Cleared 9 Mar 1983

• Ps Medical Csf-on/Off Flushing Reservoir

  Class II

  FDA 510(k) K896167 Active Cleared 21 Dec 1989

See all devices from Pudenz-Schulte Medical Research Corp. →