FDA 510(k) Application Details - K241768

Device Classification Name	More FDA Info for this Device
510(K) Number	K241768
Device Name	Broadway 8 Catheter
Applicant	Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Shazia Hakim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2024
Decision Date	12/19/2024
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	N
Expedited Review