Cleared Special

AC3? Range? Intra-Aortic Balloon Pump

K250542 · Arrow International, LLC · Cardiovascular

Mar 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K250542 is an FDA 510(k) clearance for the AC3? Range? Intra-Aortic Balloon Pump, a System, Balloon, Intra-aortic And Control (Class II — Special Controls, product code DSP), submitted by Arrow International, LLC (Morrisville, US). The FDA issued a Cleared decision on March 26, 2025, 30 days after receiving the submission on February 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number	K250542 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2025
Decision Date	March 26, 2025
Days to Decision	30 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF