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Kontron Intra-Aortic Balloon Pump, Model Kaat II

by Kontron Instruments, Inc. 510(k)

Active United States

510(k) K905313

Overview

The Kontron Intra-Aortic Balloon Pump, Model Kaat II is a system consisting of an inflatable balloon and control device. It is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies. The control system regulates the inflation and deflation of the balloon.

This device is supplied as a prescription system and is intended for single-use. It is classified as a System, Balloon, Intra-Aortic And Control with FDA 510K clearance (K905313). The device is regulated under product code DSP and is not indicated for MRI use.

AI-generated from registry data, 26 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 NumberK905313 Date19 Jun 1991ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DSP
Device Class
Class II
Regulation
21 CFR Part 870.3535
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Kontron Intra-Aortic Balloon Pump, Model Kaat II used for?

    It is used to improve cardiovascular functioning during certain life-threatening emergencies by inflating and deflating a balloon in the aorta.

  • Is the Kaat II Intra-Aortic Balloon Pump System supplied sterile?

    The description does not explicitly state that the device is supplied sterile, but it is intended for single-use.

  • What is the regulatory classification of the Kaat II device?

    The device is classified as a System, Balloon, Intra-Aortic And Control with FDA 510K clearance, regulated under product code DSP.

  • Can the Kaat II Intra-Aortic Balloon Pump System be used for MRI procedures?

    No, the device is not indicated for MRI use.