EnsoETM— 510(k) K180244

Name: FDA 510(k) clearance K180244
Creator: U.S. Food and Drug Administration
Published: 2018-02-28

Substantially Equivalent

Advanced Cooling Therapy, Inc. D/B/A Attune Medical

FDA 510(k) clearance K180244 for EnsoETM, Substantially Equivalent on 2018-02-28. Applicant: Advanced Cooling Therapy, Inc. D/B/A Attune Medical. Device class: 2.

Clearance details

Applicant: Advanced Cooling Therapy, Inc. D/B/A Attune Medical
Product code: Code PLA
Device class: Class 2
Regulation: 21 CFR 870.5910
Advisory panel: Cardiovascular
Date received: 2018-01-29
Decision date: 2018-02-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLA

view all

K250632 — Arctx Cool Catheter Set2025-10-30
K233357 — EsoCool Thermal Regulation Catheter2024-06-27
K180742 — EnsoETM2018-05-17
K172029 — EnsoETM2018-01-05
K172493 — EnsoETM2017-10-17

More clearances from Advanced Cooling Therapy, Inc. D/B/A Attune Medical

view all

DEN230021 — ensoETM2023-09-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.