FDA 510(k) Application Details - K241239

Device Classification Name	Set, Perfusion, Kidney, Disposable   More FDA Info for this Device
510(K) Number	K241239
Device Name	Set, Perfusion, Kidney, Disposable
Applicant	Bridge to Life Ltd 707 Skokie Blvd, Ste.340 Northbrook, IL 60062 US Other 510(k) Applications for this Company
Contact	Mark Harper Other 510(k) Applications for this Contact
Regulation Number	876.5880   More FDA Info for this Regulation Number
Classification Product Code	KDL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2024
Decision Date	01/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review