FDA 510(k) Application Details - K250326

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K250326
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	Spectrum Medical S.r.l. Via di Mezzo, 23 Mirandola 41037 IT Other 510(k) Applications for this Company
Contact	Raffaella Tommasini Other 510(k) Applications for this Contact
Regulation Number	870.4360   More FDA Info for this Regulation Number
Classification Product Code	KFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2025
Decision Date	06/24/2025
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