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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
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