Cleared Special

AC3? Series IABP

K232343 · Arrow International, LLC · Cardiovascular
Aug 2023
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K232343 is an FDA 510(k) clearance for the AC3? Series IABP, 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 August 30, 2023, 26 days after receiving the submission on August 4, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number K232343 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2023
Decision Date August 30, 2023
Days to Decision 26 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSP — System, Balloon, Intra-aortic And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3535

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