Identity
- Trade Name
- Paradise® Catheter FDA UDI
- Generic Name
- Renal denervation ultrasound system catheter FDA UDI
- Device Name
- PRDS-065-02 Paradise® Catheter 5mm FDA UDI
- Model / Reference
- PRDS-065-02 FDA UDI
- Description
- PRDS-065-02 Paradise® Catheter 5mm FDA UDI
Identifiers
- Catalog Number
- PRDS-065-02 FDA UDI
- Primary DI / UDI-DI
- 00810008950012 FDA UDI
- PMA Number
- P220023 FDA UDI
- FDA Product Code
- QYI FDA UDI
- GMDN Term
- Renal denervation ultrasound system catheter FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Balloon Diameter — 5 Millimeter FDA UDI
Category: Renal denervation ultrasound system catheter
Paradise® Catheter by Recor Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P220023 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Recor Medical, Inc.
Sources (1)
- FDA UDI 991e5c59-7341-4a72-ae13-f299bd0d12a7 38 fields · synced May 30, 2026