FDA 510(k) Application Details - K191687

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K191687
Device Name	Wire, Guide, Catheter
Applicant	phenox Limited Kamrick Court, Ballybrit Business Park Galway H91XY38 IE Other 510(k) Applications for this Company
Contact	Gary Brogan 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	06/24/2019
Decision Date	10/09/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review