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ESOPHAGEAL COOLING DEVICE

DEN140018 Class II Direct
Decision Date
2015-06-23
Sponsor / Applicant
Advanced Cooling Therapy, LLC

Technical Specification

510(k) Submission ID DEN140018
Product Code PLA
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.5910
Decision Date 2015-06-23
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

ESOPHAGEAL COOLING DEVICE received FDA 510(k) clearance under submission number DEN140018, sponsored by Advanced Cooling Therapy, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-06-23.

Classification & Regulation

This clearance is catalogued under FDA product code PLA and 21 CFR 870.5910, within the Cardiovascular review panel as a Class II device.