Medical Device Manufacturer · US , Chicago , IL

Advanced Cooling Therapy, LLC - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 2015

3

Total

2

Cleared

1

Denied

FDA 510(k) Regulatory Record - Advanced Cooling Therapy, LLC Cardiovascular ✕

3 devices

1-3 of 3

Cleared Mar 30, 2017

Esophageal Cooling Device

Cardiovascular · 86d

Cleared Jan 15, 2016

Esophageal Cooling Device

Cardiovascular · 140d

Not Cleared Jun 23, 2015

ESOPHAGEAL COOLING DEVICE

DEN140018 · PLA

Cardiovascular · 410d