FDA 510(k) Application Details - K152957

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K152957
Device Name	Catheter, Percutaneous
Applicant	ROXWOOD MEDICAL, INC. 400 SEAPORT CT, SUITE #103 REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	Grace Li 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	10/07/2015
Decision Date	03/04/2016
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