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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K260043
Device Name Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
Applicant
Smart Reactors
1st Floor, Block 15, Galway Technology Park
Parkmore Rd.
Galway,  IE H91 AY0Y
Applicant Contact Mark Brassil
Correspondent
Psephos Biomedica
Sussex Innovation Centre
Science Park Sq.
Falmer,  GB BN1 9SB
Correspondent Contact Robin Stephens
Regulation Number870.4210
Classification Product Code
DWF  
Date Received01/07/2026
Decision Date 02/23/2026
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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