ReCor Paradise Catheter
FDA premarket approval P220023/S009 · decided 2025-09-11
Approval details
- PMA number
- P220023
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ReCor Paradise Catheter
- Generic name
- Ablation catheter, renal denervation
- Applicant
- Recor Medical, Inc.
- Date received
- 2025-08-22
- Decision date
- 2025-09-11
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- QYI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Palo Alto, CA
- Statement
- automated processes for determining transducer measurements and programming parameters into the catheter EEPROM
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