Product Classification

• Device: ablation catheter, renal denervation
• Definition: For denervating the renal nerves to lower blood pressure
• Physical State: Catheter and generator
• Technical Method: Catheter delivered near the renal nerves to deliver energy to cause denervation
• Target Area: Renal vasculature and nerves
• Review Panel: Cardiovascular
• Product Code: QYI
• Premarket Review: Office of Cardiovascular Devices (OHT2); Coronary and Peripheral Interventional Devices (DHT2C)
• Submission Type: PMA
• Device Class: 3
• 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