BOSS 8F Balloon Guide Catheter

Catheter, Percutaneous, Neurovasculature

Marblehead Medical LLC

The following data is part of a premarket notification filed by Marblehead Medical Llc with the FDA for Boss 8f Balloon Guide Catheter.

Pre-market Notification Details

Device IDK203840
510k NumberK203840
Device Name:BOSS 8F Balloon Guide Catheter
ClassificationCatheter, Percutaneous, Neurovasculature
Applicant Marblehead Medical LLC 753 Fox Chase Rd SW Rochester Mn,  MN  55902 -8749
ContactKristin M. Mortenson
CorrespondentKristin M. Mortenson
Marblehead Medical LLC 753 Fox Chase Rd SW Rochester Mn,  MN  55902 -8749
Product CodeQJP  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-31
Decision Date2021-01-28

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