FDA 510(k) Application Details - K141618

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K141618
Device Name	Catheter, Ultrasound, Intravascular
Applicant	ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX I 2400 BERNVILLE ROAD READING, PA 19605 US Other 510(k) Applications for this Company
Contact	ELIZABETH DUNCAN Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2014
Decision Date	07/08/2014
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