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FDA 510(k)

EsoCool Thermal Regulation Catheter

K-Number: K233357 · 2024-06-27

ApplicantNuvaira, Inc.
Decision Date2024-06-27
Product CodePLA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EsoCool Thermal Regulation Catheter is a medical device manufactured by Nuvaira, Inc.. It received FDA 510(k) clearance on 2024-06-27 under approval number K233357. The device is classified under product code PLA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EsoCool Thermal Regulation Catheter?

EsoCool Thermal Regulation Catheter is a medical device that received FDA 510(k) clearance on 2024-06-27. It is manufactured by Nuvaira, Inc.. The 510(k) number is K233357.

When was EsoCool Thermal Regulation Catheter approved by the FDA?

EsoCool Thermal Regulation Catheter received FDA 510(k) clearance on 2024-06-27, under approval number K233357.

What company makes EsoCool Thermal Regulation Catheter?

EsoCool Thermal Regulation Catheter is manufactured by Nuvaira, Inc..

What is the FDA product code for EsoCool Thermal Regulation Catheter?

The FDA product code for EsoCool Thermal Regulation Catheter is PLA.

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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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