Search Results
Found 1 results
510(k) Data Aggregation
K Number
K200674Device Name
AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector
Manufacturer
Atrility Medical, LLC
Date Cleared
2020-07-02
(108 days)
Product Code
DSA, CLA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
Atrility Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AtriAmp supports pacing by acting as an extension cable between an external pacemaker and cardiac pacing leads. The AtriAmp also supports monitoring of intra-cardiac signals to one of the unipolar precordial chest leads (leads V1-V6) of a Type CF, defibrillation-proof ECG monitor.
Device Description
The AtriAmp acts as a connection hub for these three systems (external pacemaker, patient contacting external pacemaker lead wires and cardiac monitor) to provide a real-time, continuous atrial electrogram to the cardiac monitor while simultaneously allowing pacing of the atriAmp is a sterile, single patient use device.
Ask a Question
Page 1 of 1