Cleared Traditional

Quantum Mini Ventilation Module

K210669 · Spectrum Medical , Ltd. · Cardiovascular
May 2021
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K210669 is an FDA 510(k) clearance for the Quantum Mini Ventilation Module, a Gas Control Unit, Cardiopulmonary Bypass (Class II — Special Controls, product code DTX), submitted by Spectrum Medical , Ltd. (Gloucestershire, GB). The FDA issued a Cleared decision on May 4, 2021, 60 days after receiving the submission on March 5, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4300.

Submission Details

510(k) Number K210669 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2021
Decision Date May 04, 2021
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTX — Gas Control Unit, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4300

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