FDA 510(k) Application Details - K192239

Device Classification Name	More FDA Info for this Device
510(K) Number	K192239
Device Name	WavelinQ Plus EndoAVF System
Applicant	C.R. Bard, Inc. 1625 West 3rd Street Tempe, AZ 85281 US Other 510(k) Applications for this Company
Contact	Kulveen Dhatt Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2019
Decision Date	10/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review