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U.S. Department of Health and Human Services

Product Classification

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Device surgical device, for ablation of cardiac tissue
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition For surgical ablation and coagulation of cardiac tissue.
Physical State The device features an ablative surface electrode which comes into contact with the target tissue and which delivers the ablation energy.
Technical Method The device applies thermal energy to coagulate and ablate cardiac tissue.
Target Area Heart tissue.
Regulation Medical Specialty General & Plastic Surgery
Review Panel Cardiovascular
Product CodeOCL
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Electrophysiology Devices Branch (CEDB)
Submission Type 510(k)
Regulation Number 878.4400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons