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U.S. Department of Health and Human Services

Product Classification
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Device electrosurgical, cutting & coagulation & accessories, for cardiac electrophysiology device implantation and revision
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Surgical device used to dissect cardiac tissue for the implantation and revision of cardiac electrophysiology leads
Physical State Electrocautery system and accessories with radiofrequency generator and probe
Technical Method Delivers radiofrequency energy through a probe to cut and coagulate targeted cardiac tissue
Target Area Cardiac tissue where electrophysiology implants will be placed
Regulation Medical Specialty General & Plastic Surgery
Review Panel Cardiovascular
Product CodeSFQ
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 878.4400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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