MultiCath, AcQRate Dx Fixed Curve Catheter

Catheter, Electrode Recording, Or Probe, Electrode Recording

Biotronik, Inc

The following data is part of a premarket notification filed by Biotronik, Inc with the FDA for Multicath, Acqrate Dx Fixed Curve Catheter.

Pre-market Notification Details

Device IDK201445
510k NumberK201445
Device Name:MultiCath, AcQRate Dx Fixed Curve Catheter
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant Biotronik, Inc 6024 Jean Road Lake Oswego,  OR  97035
ContactJon Brumbaugh
CorrespondentJon Brumbaugh
Biotronik, Inc 6024 Jean Road Lake Oswego,  OR  97035
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2021-09-02

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