K233357
- 510(k) number
- K233357
- Device name
- EsoCool Thermal Regulation Catheter
- Applicant
- Nuvaira, Inc. MN · US
- Product code
- PLA — Esophageal Thermal Regulation And Gastric Suctioning
- Decision date
- 2024-06-27
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233357.pdf
Official FDA record: K233357
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.