FDA 510(k) Application Details - K203840

Device Classification Name	More FDA Info for this Device
510(K) Number	K203840
Device Name	BOSS 8F Balloon Guide Catheter
Applicant	Marblehead Medical LLC 753 Fox Chase Rd SW Rochester MN, MN 55902-8749 US Other 510(k) Applications for this Company
Contact	Kristin M. Mortenson 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	12/31/2020
Decision Date	01/28/2021
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