IntellaMap Orion High Resolution Mapping Catheter

Catheter, Electrode Recording, Or Probe, Electrode Recording

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Intellamap Orion High Resolution Mapping Catheter.

Pre-market Notification Details

Device IDK220796
510k NumberK220796
Device Name:IntellaMap Orion High Resolution Mapping Catheter
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant Boston Scientific Corporation 4100 Hamline Ave North St. Paul,  MN  55112
ContactMelissa Schneider
CorrespondentMelissa Schneider
Boston Scientific Corporation 4100 Hamline Ave North St. Paul,  MN  55112
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-18
Decision Date2022-06-10

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