510(k) K233357
K233357 is an FDA 510(k) premarket notification submitted by Nuvaira, Inc. for the device "EsoCool Thermal Regulation Catheter". The FDA issued a decision of Substantially Equivalent on Jun 27, 2024. The device falls under product code PLA (Esophageal Thermal Regulation And Gastric Suctioning Device), a Class II device regulated under 21 CFR 870.5910.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 27, 2024
- Date Received
- Sep 29, 2023
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esophageal Thermal Regulation And Gastric Suctioning Device
- Device Class
- Class II
- Regulation Number
- 870.5910
- Review Panel
- CV
- Submission Type
The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.