FDA 510(k) Application Details - K222170

Device Classification Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted   More FDA Info for this Device
510(K) Number	K222170
Device Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Applicant	Health Line International Corporation 260 North Ace Yeager Court, Unit D Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Aaron G Faulkner Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	NIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2022
Decision Date	01/13/2023
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