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8 Fr. -30CC Narrowflex Sheathless Intra-Aortic Balloon Catheter, Product Number IAB-04830S

by Arrow Intl., Inc.

510(k) K963865

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963865 Date16 Sep 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an intra-aortic balloon catheter system designed for temporary mechanical circulatory support. It consists of a balloon catheter inserted into the aorta to assist cardiac function.

It is supplied as a sheathless device with a stainless steel inner lumen and plastic outer lumen, and is intended for single-use. The product is regulated under FDA 510(k) clearance K963865 and classified as a Class II device with product code DSP.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER used for?

    This device is designed for temporary mechanical circulatory support by assisting cardiac function through counterpulsation in the aorta, helping to increase coronary perfusion and reduce cardiac workload during critical care situations.

  • How is the IAB-04830S supplied and is it reusable?

    The catheter is supplied as a sheathless system with a stainless steel inner lumen and plastic outer lumen, and is intended for single-use only; it is not designed, tested, or labeled for reuse, reprocessing, or resterilization due to risks of material degradation and contamination.

  • What are the key specifications of the IAB-04830S intra-aortic balloon catheter?

    The device has an 8 French diameter and a 30cc balloon volume, features a sheathless design with a stainless steel inner lumen and plastic outer lumen for stiffness and torque control, and is identified by product number IAB-04830S under manufacturer Arrow Intl., Inc.