FDA 510(k) Application Details - K203575

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K203575
Device Name	Catheter, Hemodialysis, Implanted
Applicant	C.R. Bard, Inc. 1625 W. Third Street Tempe, AZ 85281 US Other 510(k) Applications for this Company
Contact	Joan Bergstrom Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	MSD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2020
Decision Date	07/01/2021
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