FDA 510(k)

EsoCool Thermal Regulation Catheter

K-Number: K233357 · 2024-06-27

Decision Date2024-06-27

Product CodePLA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Devices (Code: PLA)

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.

K250632Arctx Cool Catheter SetArctx Medical K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical K172029EnsoETMAttune Medical K172493EnsoETMAttune Medical K170009Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC

Official Source

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