FDA 510(k) Application Details - K162253

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K162253
Device Name	Catheter, Percutaneous
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	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2016
Decision Date	01/06/2017
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