FDA 510(k) Application Details - K113849

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K113849
Device Name	Introducer, Catheter
Applicant	ALSEAL ESPACE VALENTIN- VALPARC 6C, RUE DE FRANCHE-COMTE BESANCON 25048 FR Other 510(k) Applications for this Company
Contact	JEAN-FRANCOIS DELFORGE 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	12/29/2011
Decision Date	07/31/2012
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	Y
Expedited Review