Cleared Special

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

K200634 · Arrow International, Inc. · Cardiovascular
Apr 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K200634 is an FDA 510(k) clearance for the Arrow FiberOptix Intra-Aortic Balloon Catheter Kit, 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 April 9, 2020, 30 days after receiving the submission on March 10, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number K200634 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2020
Decision Date April 09, 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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