FDA 510(k) Application Details - K203363

Device Classification Name	More FDA Info for this Device
510(K) Number	K203363
Device Name	Crosser iQ CTO Recanalization System
Applicant	C.R. Bard, Inc. 1625 West 3rd St Tempe, AZ 85281 US Other 510(k) Applications for this Company
Contact	Aaron Conovaloff 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	11/16/2020
Decision Date	08/12/2021
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