8FR. Narrowflex Universal Intra-Aortic Balloon Catheter

• • Ongoing Z-1880-2024 FDA Class I ·initiated 29 Apr 2024

  Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

510(k) Number

K993966 ↗

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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See all devices from Arrow Intl., Inc. →

• What is the purpose of the 8Fr. Narrowflex Universal Intra-Aortic Balloon Catheter?

  This device is used in cardiovascular procedures to provide intra-aortic counterpulsation. It is inserted into the aorta to assist in improving coronary artery perfusion and reducing cardiac workload during clinical procedures.

• Is the 8Fr. Narrowflex Universal Intra-Aortic Balloon Catheter single-use or reusable?

  The catheter is supplied as a single-use device and requires appropriate storage conditions. It is intended for use in clinical settings under professional supervision and should not be reused for patient safety reasons.

• What is the regulatory status of this device?

  The device has received FDA 510(k) clearance with the product code DSP and is classified as Class II. It was determined to be substantially equivalent to other devices in this category for its intended use in cardiovascular procedures.

• How is the 8Fr. Narrowflex Universal Intra-Aortic Balloon Catheter supplied?

  The catheter is supplied as a single-use device in packaging that maintains its sterility and functionality until use. It requires appropriate storage conditions as specified by the manufacturer to ensure proper performance when needed in clinical settings.