EnsoETM— 510(k) K172493

Substantially Equivalent

Attune Medical

FDA 510(k) clearance K172493 for EnsoETM, Substantially Equivalent on 2017-10-17. Applicant: Attune Medical. Device class: 2.

Clearance details

Applicant: Attune Medical
Product code: Code PLA
Device class: Class 2
Regulation: 21 CFR 870.5910
Advisory panel: Cardiovascular
Date received: 2017-08-18
Decision date: 2017-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLA

K250632 — Arctx Cool Catheter Set2025-10-30
K233357 — EsoCool Thermal Regulation Catheter2024-06-27
K180742 — EnsoETM2018-05-17
K180244 — EnsoETM2018-02-28
K172029 — EnsoETM2018-01-05

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