P-S Medical Ventricular Access Port

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K874468 ↗

FDA Product Code

LKG

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. →

• What is the P-S Medical Ventricular Access Port used for?

  The P-S Medical Ventricular Access Port is designed for long-term access to the brain’s ventricular system. It enables clinicians to safely collect cerebrospinal fluid (CSF) samples, drain excess fluid, or administer therapeutic agents—critical for managing conditions like hydrocephalus or delivering targeted treatments in neurology.

• Is the device intended for reuse or single-use?

  The P-S Medical Ventricular Access Port is supplied sterile and intended for single-use implantation only. Reuse violates sterility requirements and compromises patient safety, as the device is not designed for repeated procedures.

• How should the port be stored before use?

  The device must be stored according to sterile medical device protocols to preserve its integrity. It should remain in its original packaging until immediately before implantation, protected from contamination and physical damage. Avoid exposure to extreme temperatures or moisture.

• What components does the system include?

  The system consists of a subcutaneous reservoir (implanted under the skin) connected via a catheter to the intraventricular space of the brain. This design allows minimally invasive access for CSF-related procedures without repeated surgical interventions.

• Does the port require special handling or regulatory compliance?

  Yes, the port adheres to FDA 510(k) clearance (K874468) and 21 CFR Part 882.5550 standards. It is classified under FDA product code LKG (Port & Catheter) and is intended for neurology applications. Sterility and single-use compliance are non-negotiable for safe implantation.