PS Medical IPI Access Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K930206 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

• 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 PS Medical IPI Access Kit used for?

  The PS Medical IPI Access Kit is a port and catheter system designed for implantation as a subcutaneous and intravascular device. It provides vascular access for medical procedures requiring repeated administration of fluids, medications, or blood products.

• Is the PS Medical IPI Access Kit a single-use or reusable device?

  The device is supplied as a single-use kit, meaning it is intended for one-time use only and should not be reused or resterilized for subsequent patient procedures.

• What is the regulatory status of the PS Medical IPI Access Kit?

  The device is regulated under FDA 510(k) clearance with product code LJT, which means it has been cleared by the FDA as substantially equivalent to predicate devices already on the market.

• In what type of setting is the PS Medical IPI Access Kit intended to be used?

  The device is intended for use in general hospital settings, where it can be implanted to provide vascular access for various medical procedures requiring repeated administration of fluids, medications, or blood products.