Gatekeeper Balloon Catheter

Catheter, Intravascular Occluding, Temporary

Arch Catheter, LLC

The following data is part of a premarket notification filed by Arch Catheter, Llc with the FDA for Gatekeeper Balloon Catheter.

Pre-market Notification Details

Device IDK192786
510k NumberK192786
Device Name:Gatekeeper Balloon Catheter
ClassificationCatheter, Intravascular Occluding, Temporary
Applicant Arch Catheter, LLC 621 Grand Harbor Boulevard Ninety Six,  SC  29666
ContactMichael Zhadkevich
CorrespondentMary Vater
Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury,  VT  05738
Product CodeMJN  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-04-25

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