FDA 510(k) Application Details - K212588

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K212588
Device Name	Catheter, Percutaneous
Applicant	C.R. Bard, Inc 1625 W Third Street Tempe, AZ 85281 US Other 510(k) Applications for this Company
Contact	Arieona Boyle Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2021
Decision Date	05/04/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review