Cleared Traditional

AC3 Series IABP System

K162820 · Arrow International, Inc. · Cardiovascular
Mar 2017
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K162820 is an FDA 510(k) clearance for the AC3 Series IABP System, a System, Balloon, Intra-aortic And Control (Class II — Special Controls, product code DSP), submitted by Arrow International, Inc. (Chelmsford, US). The FDA issued a Cleared decision on March 31, 2017, 175 days after receiving the submission on October 7, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number K162820 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2016
Decision Date March 31, 2017
Days to Decision 175 days
Submission Type Traditional
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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