Medtronic Ps Medical Bioglide Vascular Catheter, Sngl Lumen Model Nos 8960 & 8932

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

510(k) Number

K960055 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

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 Medtronic Ps Medical Bioglide Vascular Catheter used for?

  The Medtronic Ps Medical Bioglide Vascular Catheter is a single lumen device used for vascular access and is designed to be implanted. It is intended for therapeutic use as a long-term intravascular catheter greater than 30 days.

• What are the potential complications associated with this catheter?

  The device is susceptible to complications including catheter malposition, occlusion, fibrin sheath formation, dislodgment, rupture, and exit site necrosis, which should be considered during implantation and patient monitoring.

• How is the Medtronic Ps Medical Bioglide Vascular Catheter supplied?

  The catheter is supplied with model numbers 8960 and 8932, which are the specific single lumen variants of this vascular access device.

• What is the regulatory status of this device?

  The Medtronic Ps Medical Bioglide Vascular Catheter has FDA 510K authorization, classified under regulation number 880.5970 and product code LJS, indicating it has been determined to be substantially equivalent to predicate devices.