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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Console, Heart-Lung Machine, Cardiopulmonary Bypass
510(k) Number K190282
Device Name Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
Applicant
Spectrum Medical , Ltd.
Harrier 4, Meteor Business Park, Cheltenham Rd. E.
Gloucester,  GB GL2 9QL
Applicant Contact Colleen Powell
Correspondent
Spectrum Medical , Ltd.
Harrier 4, Meteor Business Park, Cheltenham Rd. E.
Gloucester,  GB GL2 9QL
Correspondent Contact Colleen Powell
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received02/11/2019
Decision Date 05/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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