Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Advanced Cooling Therapy, LLC. It received FDA 510(k) clearance on 2016-01-15 under approval 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. It is manufactured by Advanced Cooling Therapy, LLC. The 510(k) number is K152450.

When was Esophageal Cooling Device approved by the FDA?

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

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.

Related Clinical Trials

NCT04183218 Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes COMPLETED NCT04764357 Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors RECRUITING NCT07421882 PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE) RECRUITING NCT06228144 Radio-Frequency Microneedling Device TERMINATED NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION NCT07539714 Development of an Active Heat Dissipation Device Based on Thermoelectric Cooling Technology: Aiming to Improve Endurance Sports Performance ACTIVE_NOT_RECRUITING

Other Devices by Advanced Cooling Therapy, LLC

K170009Esophageal Cooling Device

Related Devices (Code: PLA)

K172493EnsoETMAttune Medical K170009Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC 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.

↑