FDA 510(k) Application Details - K212725

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K212725
Device Name	Catheter, Percutaneous
Applicant	Cardiovascular Systems, Inc. 1225 Old Highway 8 NW St. 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	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2021
Decision Date	09/24/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review