FDA 510(k) Application Details - K182457

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K182457
Device Name	Wire, Guide, Catheter
Applicant	Brivant Limited (Lake Region Medical) Parkmore West Business Park Galway H91 CK22 IE Other 510(k) Applications for this Company
Contact	Tom J. Healy Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2018
Decision Date	04/18/2019
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