FDA 510(k) Application Details - K233515

Device Classification Name	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use   More FDA Info for this Device
510(K) Number	K233515
Device Name	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Applicant	Nuwellis Inc. 12988 Valley View Road Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	Dawn Li Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	NQJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2023
Decision Date	12/26/2023
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