Cleared Traditional

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

K192838 · Spectrum Medical , Ltd. · Cardiovascular
Apr 2020
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K192838 is an FDA 510(k) clearance for the Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure, a Control, Pump Speed, Cardiopulmonary Bypass (Class II — Special Controls, product code DWA), submitted by Spectrum Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on April 13, 2020, 193 days after receiving the submission on October 3, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number K192838 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2019
Decision Date April 13, 2020
Days to Decision 193 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWA — Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4380

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