FDA 510(k)

EsoCool Thermal Regulation Catheter

Número K: K233357 · 2024-06-27

Data da decisão2024-06-27

Código do produtoPLA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Nuvaira, Inc.. The 510(k) number is K233357.

When did EsoCool Thermal Regulation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for EsoCool Thermal Regulation Catheter?

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

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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Fonte oficial

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