FDA 510(k) Application Details - K200198

Device Classification Name	Temporary Carotid Catheter For Embolic Capture   More FDA Info for this Device
510(K) Number	K200198
Device Name	Temporary Carotid Catheter For Embolic Capture
Applicant	Cardiovascular Systems, Inc 1225 Old Hwy 8 NW Saint Paul, MN 55112 US Other 510(k) Applications for this Company
Contact	Erika Huffman Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	NTE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2020
Decision Date	03/18/2020
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