Cleared Traditional

UltraFlex IAB

K190101 · Arrow International, Inc. · Cardiovascular
Jun 2019
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K190101 is an FDA 510(k) clearance for the UltraFlex 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 28, 2019, 157 days after receiving the submission on January 22, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number K190101 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2019
Decision Date June 28, 2019
Days to Decision 157 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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