8 Fr.-40cc Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number Iab-04840(Used with a 9FR.SHEATH)

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

510(k) Number

K960713 ↗

FDA Product Code

DSP

Device Class

Class II

Regulation

21 CFR Part 870.3535

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Brachial Plexus Catheter - Bp-01200

  Class II

  FDA 510(k) K874105 Active Cleared 24 Nov 1987

• A2 Port, Dual Lumen System With Detached Catheter, Catalog # AP-01518

  Class II

  FDA 510(k) K963684 Active Cleared 24 Oct 1996

• Arrow Picc-Peripherally Inserted Central Catheter

  Class II

  FDA 510(k) K930129 Active Cleared 28 Mar 1994

• Hemosonic 200HEMODYNAMIC Monitor

  Class II

  FDA 510(k) K040802 Active Cleared 28 Apr 2004

• Needleless Injection Cannula

  Class II

  FDA 510(k) K923653 Active Cleared 13 May 1993

• Arrow Echogenic Introducer Needle Component

  Class II

  FDA 510(k) K071998 Active Cleared 26 Sep 2007

See all devices from Arrow Intl., Inc. →

• What clinical indications is the Arrow Flex IAB-04840 designed for?

  This intra-aortic balloon catheter is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure. It serves as a temporary circulatory support device within the aorta when used with an intra-aortic balloon pump control system.

• How is the device supplied and is it intended for single or multiple patient use?

  The device is supplied as a single-use, sterile product. It is intended for one-time clinical use and should be discarded after the procedure, in accordance with the manufacturer's labeling and standard infection control practices.

• What are the key dimensional and compatibility specifications of this catheter?

  The catheter has an 8 French diameter and a 40 cc balloon volume. It is designed to be used in conjunction with a 9 French sheath, which is necessary for proper insertion and function during temporary cardiac support procedures.

• Under what regulatory classification and product code is this device categorized?

  The device is classified under FDA product code DSP and is regulated under 21 CFR 870.3535 as a Class II device. This classification reflects its role as a temporary circulatory support system with established safety and performance standards.

• What storage and handling conditions should be followed prior to use?

  Specific storage conditions and handling instructions are detailed in the manufacturer's labeling. Healthcare professionals should consult the product insert for guidance on proper storage, inspection, and preparation before clinical use to ensure device integrity and patient safety.