Emprint SX Ablation Platform With Thermosphere Technology

System, Ablation, Microwave And Accessories

Covidien, LLC

The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Emprint Sx Ablation Platform With Thermosphere Technology.

Pre-market Notification Details

Device IDK203303
510k NumberK203303
Device Name:Emprint SX Ablation Platform With Thermosphere Technology
ClassificationSystem, Ablation, Microwave And Accessories
Applicant Covidien, LLC 5920 Longbow Dr Boulder,  CO  80301
ContactLiron Bar-yaakov
CorrespondentLiron Bar-yaakov
Covidien, LLC 5920 Longbow Dr Boulder,  CO  80301
Product CodeNEY  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-09
Decision Date2020-12-17

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