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FDA 510(k)

Esophageal Cooling Device

K-Number: K152450 · 2016-01-15

ApplicantAdvanced Cooling Therapy, LLC
Decision Date2016-01-15
Product CodePLA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Esophageal Cooling Device is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cooling Therapy, LLC. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K152450. 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 2016-01-15. The listed applicant is Advanced Cooling Therapy, LLC. The 510(k) number is K152450.

When did Esophageal Cooling Device receive FDA 510(k) clearance?

Esophageal Cooling Device received FDA 510(k) clearance on 2016-01-15, under 510(k) number K152450.

Who is the listed applicant for Esophageal Cooling Device?

The FDA 510(k) record lists Advanced Cooling Therapy, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Esophageal Cooling Device?

The FDA product code for Esophageal Cooling Device is PLA.

Other records listing Advanced Cooling Therapy, LLC as applicant

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.

K170009Esophageal Cooling Device

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 MedicalK233357EsoCool Thermal Regulation CatheterNuvaira, Inc.K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune MedicalK180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune MedicalK172029EnsoETMAttune MedicalK172493EnsoETMAttune Medical

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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