FDA 510(k) Application Details - K240908

Device Classification Name	Heat-Exchanger, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K240908
Device Name	Heat-Exchanger, Cardiopulmonary Bypass
Applicant	Spectrum Medical Ltd. Harrier 4, Meteor Business Park, 128 Cheltenham Road East Gloucester GL2 9QL GB Other 510(k) Applications for this Company
Contact	Asia Lukuc Other 510(k) Applications for this Contact
Regulation Number	870.4240   More FDA Info for this Regulation Number
Classification Product Code	DTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2024
Decision Date	07/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review