FDA 510(k) Application Details - K191078

Device Classification Name	More FDA Info for this Device
510(K) Number	K191078
Device Name	BAROnova Access Sheath Kit
Applicant	BAROnova, Inc. 1551 Industrial Road San Carlos, CA 94070 US Other 510(k) Applications for this Company
Contact	Lian Cunningham Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2019
Decision Date	07/22/2019
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