AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector

Cable, Transducer And Electrode, Patient, (including Connector)

Atrility Medical, LLC

The following data is part of a premarket notification filed by Atrility Medical, Llc with the FDA for Atriamp, Atriamp - Pacing Cable Medtronic Connector, Atriamp - Pacing Cable Oscor Connector.

Pre-market Notification Details

Device IDK200674
510k NumberK200674
Device Name:AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
Applicant Atrility Medical, LLC 313 Price Place, Suite 13 Madison,  WI  53705
ContactMatthew Knoespel
CorrespondentGary Syring
Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton,  WI  53589
Product CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-16
Decision Date2020-07-02

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