FDA 510(k) Application Details - K192625

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K192625
Device Name	Catheter, Percutaneous
Applicant	MicroVention, Inc., A Terumo Group Company 35 Enterprise Aliso Viejo, CA 92656 US Other 510(k) Applications for this Company
Contact	Ganesh Balachandar 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	09/23/2019
Decision Date	11/21/2019
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