FDA 510(k) Application Details - K160018

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K160018
Device Name	Wire, Guide, Catheter
Applicant	ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD READING, PA 19605 US Other 510(k) Applications for this Company
Contact	TRACY LARISH Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2016
Decision Date	06/13/2016
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