Cleared Special

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case

K163542 · Datascope Corp. · Cardiovascular
Jan 2017
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K163542 is an FDA 510(k) clearance for the CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case, a System, Balloon, Intra-aortic And Control (Class II — Special Controls, product code DSP), submitted by Datascope Corp. (Manwah, US). The FDA issued a Cleared decision on January 31, 2017, 46 days after receiving the submission on December 16, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number K163542 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2016
Decision Date January 31, 2017
Days to Decision 46 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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