FDA 510(k) Application Details - K151936

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K151936
Device Name	Introducer, Catheter
Applicant	SYNAPTIC MEDICAL LIMITED BUILDING C, 100 KECHUANG 6TH STREET, BEIJING ECO-TECH DEVELOPMENT AREA BEIJING 101111 CN Other 510(k) Applications for this Company
Contact	Yang Tiecheng Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2015
Decision Date	12/04/2015
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review