FDA 510(k) Application Details - K190843

Device Classification Name	Guide, Wire, Catheter, Neurovasculature   More FDA Info for this Device
510(K) Number	K190843
Device Name	Guide, Wire, Catheter, Neurovasculature
Applicant	Stryker 47900 Bayside Parkway Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Lorraine Mazzeo Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	MOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2019
Decision Date	05/01/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review