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

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K833822 ↗

FDA Product Code

LKG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• 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

• PS Medical IPI Access Kit

  Class II

  FDA 510(k) K930206 Active Cleared 25 Feb 1994

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

• What is the P-S MEDICAL CSF ACCESS DEV 15MM/25MM used for?

  The device is designed for cerebrospinal fluid (CSF) access and is intended for use in neurology-related clinical settings as an implanted subcutaneous intraventricular port and catheter system.

• What sizes are available for the P-S MEDICAL CSF ACCESS DEV 15MM/25MM?

  The device is available in two sizes: 15mm and 25mm, as indicated in the product name and specifications, to accommodate different anatomical or clinical needs for CSF access.

• How is the P-S MEDICAL CSF ACCESS DEV 15MM/25MM supplied and intended to be used?

  The device is supplied as an implanted system and is intended for long-term subcutaneous placement to provide access to the ventricular system for cerebrospinal fluid management in neurology care.