FDA 510(k) Application Details - K152913

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K152913
Device Name	Introducer, Catheter
Applicant	CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL PARKMORE WEST GALWAY IE Other 510(k) Applications for this Company
Contact	ORLA HICKEY 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	10/02/2015
Decision Date	07/21/2016
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