FDA 510(k) Application Details - K010913

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K010913
Device Name	Introducer, Catheter
Applicant	VYGON CORP. 1129 BLOOMFIELD AVE. WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	ROBERT SCHIFF 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	03/27/2001
Decision Date	09/28/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review