Cleared Traditional

Fiberoptix IAB

K190117 · Arrow International, Inc. · Cardiovascular
Jun 2019
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K190117 is an FDA 510(k) clearance for the Fiberoptix IAB, 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 June 13, 2019, 140 days after receiving the submission on January 24, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number K190117 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2019
Decision Date June 13, 2019
Days to Decision 140 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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