Cleared Traditional

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

K190282 · Spectrum Medical , Ltd. · Cardiovascular
May 2019
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K190282 is an FDA 510(k) clearance for the Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand), a Console, Heart-lung Machine, Cardiopulmonary Bypass (Class II — Special Controls, product code DTQ), submitted by Spectrum Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on May 24, 2019, 102 days after receiving the submission on February 11, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4220.

Submission Details

510(k) Number K190282 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2019
Decision Date May 24, 2019
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTQ — Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4220

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