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Cardiac Catherization Kit

by Abbott Laboratories 510(k)

Active United States

510(k) K914299

Overview

The Cardiac Catheterization Kit is a diagnostic intravascular catheter device used to navigate cardiac anatomy and capture critical cardiac information. It is designed to facilitate comprehensive data collection and deliver precise therapy for patients with cardiac conditions.

This kit is supplied as a single-use device and is not MRI safe. It is stored according to manufacturer instructions and has received FDA 510(k) clearance with the product code DQO. The kit is classified under Class II - Special Controls and is part of the Abbott CPS Cardiac Positioning System product portfolio.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914299 Date3 Jun 1992ClearedStatusActive

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-0055-2013 FDA Class II initiated 28 Sep 2012

    ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

Specification

510(k)

510(k) Number
FDA Product Code
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Abbott Laboratories

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Questions

  • What is the Cardiac Catheterization Kit used for?

    The Cardiac Catheterization Kit is a diagnostic intravascular catheter device used to navigate cardiac anatomy and capture critical cardiac information. It facilitates comprehensive data collection and delivers precise therapy for patients with cardiac conditions.

  • Is the Cardiac Catheterization Kit reusable or MRI safe?

    The kit is supplied as a single-use device and is not MRI safe. It is designed for one-time use only to ensure patient safety and device performance.

  • What regulatory approvals does the Cardiac Catheterization Kit have?

    The kit has received FDA 510(k) clearance with the product code DQO. It is classified under Class II - Special Controls and is part of the Abbott CPS Cardiac Positioning System product portfolio.

  • How should the Cardiac Catheterization Kit be stored?

    The kit should be stored according to manufacturer instructions to maintain its integrity and functionality. Proper storage conditions are essential to ensure the device performs as intended when used.