# K233357: EsoCool Thermal Regulation Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Nuvaira, Inc.
- Decided: Jun 27, 2024 after 272 days
- Product code: PLA (Esophageal Thermal Regulation And Gastric Suctioning Device)
- Device class: 2
- Regulation: 21 CFR 870.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN140018 (2015). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172493: EnsoETM, Attune Medical (2017) Summary page 4.

## Indications for use
The EsoCool catheter is a thermal regulating device intended to connect to a Gentherm Blanketrol III Hyper-Hypothermia System to control the patient temperature.

Source page: https://510kreport.com/device/K233357
Methodology: https://510kreport.com/methodology