EsoCool Thermal Regulation Catheter— 510(k) K233357

Name: FDA 510(k) clearance K233357
Creator: U.S. Food and Drug Administration
Published: 2024-06-27

Substantially Equivalent

Nuvaira, Inc.

FDA 510(k) clearance K233357 for EsoCool Thermal Regulation Catheter, Substantially Equivalent on 2024-06-27. Applicant: Nuvaira, Inc.. Device class: 2.

Clearance details

Applicant: Nuvaira, Inc.
Product code: Code PLA
Device class: Class 2
Regulation: 21 CFR 870.5910
Advisory panel: Cardiovascular
Date received: 2023-09-29
Decision date: 2024-06-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Maple Grove,, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLA

view all

K250632 — Arctx Cool Catheter Set2025-10-30
K180742 — EnsoETM2018-05-17
K180244 — EnsoETM2018-02-28
K172029 — EnsoETM2018-01-05
K172493 — EnsoETM2017-10-17

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