Medical Device Manufacturer · US , Morrisville , NC

Arrow International, LLC - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2023

Official Website

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Arrow International, LLC Cardiovascular ✕

2 devices

1-2 of 2

Cleared Mar 26, 2025

AC3™ Range™ Intra-Aortic Balloon Pump

Cardiovascular · 30d

Cleared Aug 30, 2023

AC3™ Series IABP

Cardiovascular · 26d