EsoCool Thermal Regulation Catheter— 510(k) K233357
Substantially EquivalentNuvaira, Inc.
FDA 510(k) clearance K233357 for EsoCool Thermal Regulation Catheter, Substantially Equivalent on 2024-06-27. Applicant: Nuvaira, Inc..
Clearance details
- Applicant
- Nuvaira, Inc.
- Product code
- Code PLA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Maple Grove,, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.