Product code PLA— Cardiovascular

EnsoETM

Advisory panel: Cardiovascular
Total cleared: 9

Recent clearances under product code PLA

K250632 — Arctx Cool Catheter SetArctx Medical·2025-10-30
K233357 — EsoCool Thermal Regulation CatheterNuvaira, Inc.·2024-06-27
K180742 — EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical·2018-05-17
K180244 — EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical·2018-02-28
K172029 — EnsoETMAttune Medical·2018-01-05
K172493 — EnsoETMAttune Medical·2017-10-17
K170009 — Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC·2017-03-30
K152450 — Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC·2016-01-15
DEN140018 — ESOPHAGEAL COOLING DEVICEAdvanced Cooling Therapy, LLC·2015-06-23

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