Paradise Ultrasound Renal Denervation System
FDA PMAEUDAMEDClass III (US FDA PMA)
Identity
- Trade Name
- Paradise® Ultrasound Renal Denervation System FDA PMA
- Generic Name
- Ablation catheter, renal denervation FDA PMA
Identifiers
- PMA Number
- P220023 FDA PMA
- FDA Product Code
- QYI FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Paradise Ultrasound Renal Denervation System is an ablation catheter designed for renal denervation procedures. It is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients who do not achieve adequate control through lifestyle changes and antihypertensive medications.
The system is supplied as a sterile, single-use device intended for use in cardiovascular interventional settings. It has received FDA PMA approval (P220023) and complies with MDD and MDR regulatory requirements.
Frequently asked questions
What is the Paradise Ultrasound Renal Denervation System used for?
The Paradise Ultrasound Renal Denervation System is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure, based on the device's intended use as stated in the specifications.
Is the Paradise Ultrasound Renal Denervation System reusable or single-use?
The device is supplied as a sterile, single-use ablation catheter, meaning it is intended for one procedure only and should not be reprocessed or reused, as indicated by its classification and typical use in interventional settings.
What regulatory authorizations does the Paradise Ultrasound Renal Denervation System have?
The system has received FDA PMA approval (P220023) and complies with MDD and MDR requirements, as explicitly listed in the AUTHORIZATIONS field of the device data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Recor Medical - Paradise Ultrasound Renal Denervation System, Recor Medical Announces Paradise Ultrasound Renal ..., P220023 - Premarket Approval (PMA) - FDA, The Paradise uRDN - - Recor Medical, Ultrasound Renal Denervation System to Treat Hypertension ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Active |
| FDA PMA | European Union | MDD | — | Class III | Pending data |
| FDA PMA | United States | FDA_PMA | P220023 | Class III | Active |
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Manufacturer
- Manufacturer
- Recor Medical, Inc.
Sources (2)
- FDA PMA P220023 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026