Optima Coil System

Device, Neurovascular Embolization

Balt USA, LLC

The following data is part of a premarket notification filed by Balt Usa, Llc with the FDA for Optima Coil System.

Pre-market Notification Details

Device IDK200030
510k NumberK200030
Device Name:Optima Coil System
ClassificationDevice, Neurovascular Embolization
Applicant Balt USA, LLC 29 Parker Irvine,  CA  92618
ContactMichael Peters
CorrespondentMichael Peters
Balt USA, LLC 29 Parker Irvine,  CA  92618
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-07
Decision Date2020-02-01

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