FDA 510(k) Application Details - K211802

Device Classification Name	More FDA Info for this Device
510(K) Number	K211802
Device Name	GoBack Crossing Catheter
Applicant	Upstream Peripheral Technologies, Ltd ARAN Building, P.O. Box 3067; 43 Haeshel Street Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Dan Rottenberg Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2021
Decision Date	03/01/2022
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