Cleared Special

AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP

K201112 · Arrow International, Inc. · Cardiovascular
May 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K201112 is an FDA 510(k) clearance for the AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP, 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 May 27, 2020, 30 days after receiving the submission on April 27, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number K201112 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2020
Decision Date May 27, 2020
Days to Decision 30 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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