FDA 510(k) Application Details - K171513

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K171513
Device Name	Wire, Guide, Catheter
Applicant	William Cook Europe ApS Sandet 6 Bjaeverskov 4632 DK Other 510(k) Applications for this Company
Contact	Henriette Stordal Christiansen 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	05/24/2017
Decision Date	12/07/2017
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