SHANGHAI GOLDEN LEAF MEDTECH Radio Frequency Renal Ablation System - HSA Registration DE0510340
Access comprehensive regulatory information for SHANGHAI GOLDEN LEAF MEDTECH Radio Frequency Renal Ablation System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510340 and owned by SHANGHAI GOLDEN LEAF MEDTECH CO., LTD. The device was registered on February 14, 2025.
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The Radio Frequency Renal Ablation Device is a high-frequency surgical instrument. The instrument is connected with matched Radio frequency Renal Ablation Catheter to output RF energy to the renal artery, to ablate the renal artery sympathetic nerve. This instrument is designed for renal artery sympathetic nerve ablation. The Radio Frequency Renal Ablation Catheter is intended to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the peripheral sympathetic nerves of the kidney. The product multi-electrode renal denervation catheter is indicated for the treatment of uncontrolled primary hypertension, whereby 'uncontrolled primary hypertension' here was defined as: office BP ≥ 150/90 and <180/110 mmHg and mean 24 h ambulatory systolic BP (SBP) ≥ 135 mmHg] despite being on stable anti- hypertensive medication regime and standardized antihypertensive therapy