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FDA 510(k)

Esophageal Cooling Device

K-Number: K170009 · 2017-03-30

ApplicantAdvanced Cooling Therapy, LLC
Decision Date2017-03-30
Product CodePLA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Esophageal Cooling Device is a medical device manufactured by Advanced Cooling Therapy, LLC. It received FDA 510(k) clearance on 2017-03-30 under approval number K170009. 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 Esophageal Cooling Device?

Esophageal Cooling Device is a medical device that received FDA 510(k) clearance on 2017-03-30. It is manufactured by Advanced Cooling Therapy, LLC. The 510(k) number is K170009.

When was Esophageal Cooling Device approved by the FDA?

Esophageal Cooling Device received FDA 510(k) clearance on 2017-03-30, under approval number K170009.

What company makes Esophageal Cooling Device?

Esophageal Cooling Device is manufactured by Advanced Cooling Therapy, LLC.

What is the FDA product code for Esophageal Cooling Device?

The FDA product code for Esophageal Cooling Device is PLA.

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Other Devices by Advanced Cooling Therapy, LLC

K152450Esophageal Cooling Device

Related Devices (Code: PLA)

K152450Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC K172493EnsoETMAttune Medical K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical K172029EnsoETMAttune Medical K233357EsoCool Thermal Regulation CatheterNuvaira, Inc.

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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