FDA 510(k) Application Details - K182937

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K182937
Device Name	Catheter, Percutaneous
Applicant	Upstream Peripheral Technologies, Ltd. ARAN Building, P.O. Box 3067; 43 Ha'Eshel Street Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Dan Rottenberg 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	10/22/2018
Decision Date	05/23/2019
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