FDA 510(k) Application Details - K200426

Device Classification Name	Catheter, Hemodialysis, Non-Implanted   More FDA Info for this Device
510(K) Number	K200426
Device Name	Catheter, Hemodialysis, Non-Implanted
Applicant	Health Line International Corporation 5675 West 300 South Salt Lake City, UT 84104 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	MPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2020
Decision Date	12/24/2020
Decision	SESK - SUBST EQUIV - KIT
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