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U.S. Department of Health and Human Services

Product Classification
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Device catheter, intracardiac mapping, high-density array
Regulation Description Electrode recording catheter or electrode recording probe.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMTD
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.1220
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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