FDA 510(k) Application Details - K190393

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K190393
Device Name	Catheter, Percutaneous
Applicant	ReFlow Medical, Inc. 208 Avenida Fabricante #100 San Clemente, CA 92672 US Other 510(k) Applications for this Company
Contact	Rebecca K Pine 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	02/19/2019
Decision Date	05/09/2019
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