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FDA PMA

Ablation catheter, renal denervation

PMA Number: P220023 · 2026-08-13

ApplicantRecor Medical, Inc.
Decision Date2026-08-13
PMA NumberP220023
Product CodeQYI
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Ablation catheter, renal denervation is the device name listed in this FDA 510(k) record. The listed applicant is Recor Medical, Inc.. It received FDA 510(k) clearance on 2026-08-13. The device is classified under product code QYI. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Ablation catheter, renal denervation?

Ablation catheter, renal denervation is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Recor Medical, Inc..

When did Ablation catheter, renal denervation receive FDA 510(k) clearance?

The clearance date for Ablation catheter, renal denervation can be found in the official FDA records.

Who is the listed applicant for Ablation catheter, renal denervation?

The FDA 510(k) record lists Recor Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ablation catheter, renal denervation?

The FDA product code for Ablation catheter, renal denervation is QYI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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