FDA 510(k) Application Details - K122854

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K122854
Device Name	Introducer, Catheter
Applicant	ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD. READING, PA 19605 US Other 510(k) Applications for this Company
Contact	JULIE LAWSON 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	09/18/2012
Decision Date	01/04/2013
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