BOSS Balloon Guide Catheter

Catheter, Percutaneous

Marblehead Medical

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

Pre-market Notification Details

Device IDK200910
510k NumberK200910
Device Name:BOSS Balloon Guide Catheter
ClassificationCatheter, Percutaneous
Applicant Marblehead Medical 11600 96th Ave N Maple Grove,  MN  55369
ContactKristin Mortenson
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-04-06
Decision Date2020-05-02

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