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CVP Polyurethane Catheter

by Abbott Laboratories 510(k)

Active United States

510(k) K961552

Overview

The CVP Polyurethane Catheter is a short-term intravascular catheter (product code FOZ), designed for insertion into the patient’s vascular system for less than 30 days. It is classified as a therapeutic device intended for monitoring central venous pressure, sampling blood, or administering intravenous fluids.

This catheter is supplied as a single-use, non-sterile device and is regulated under FDA 510(k) clearance (K961552) as substantially equivalent to a predicate device. It is intended for use in general hospital settings and adheres to Class II special controls. No MRI safety or reusable specifications are indicated in the regulatory data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961552 Date10 Feb 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0543-04 FDA Unclassified (pre-2012) initiated 17 Dec 2003

    18 gauge needles in Central Venous Catheter kits may be partially occluded.

Specification

510(k)

510(k) Number
FDA Product Code
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary purpose of the CVP Polyurethane Catheter, and how long is it intended for use in patients?

    The CVP Polyurethane Catheter is designed for short-term use (up to 30 days) in the vascular system to monitor central venous pressure, draw blood samples, or administer intravenous fluids. It is classified as a therapeutic device and is intended for general hospital settings.

  • Is this catheter reusable, or is it meant for single-use only? How is it supplied?

    The CVP Polyurethane Catheter is supplied as a single-use device and is non-sterile at the time of shipment. It is not intended for reuse or reprocessing, as indicated in the regulatory data.

  • What regulatory pathway was followed for FDA clearance of this catheter, and what does that mean for its use?

    This device received FDA 510(k) clearance (K961552) under the Traditional Review pathway, determined to be substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class II device under special controls, primarily for use in hospitals.

  • Are there any special considerations for storage or handling of this catheter?

    Since the catheter is non-sterile and single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Sterilization is not required before use, but proper aseptic techniques must be followed during insertion to minimize infection risk.