K233357 is an FDA 510(k) clearance for the EsoCool Thermal Regulation Catheter. This device is classified as a Esophageal Thermal Regulation And Gastric Suctioning Device (Class II - Special Controls, product code PLA).
Submitted by Nuvaira, Inc. (Maple Grove,, US). The FDA issued a Cleared decision on June 27, 2024, 272 days after receiving the submission on September 29, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5910. The Device Is Used To Control A Patient's Temperature, While Simultaneously Maintaining Access To The Stomach To Allow Gastric Decompression And Drainage..
| 510(k) Number | K233357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | June 27, 2024 |
| Days to Decision | 272 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PLA - Esophageal Thermal Regulation And Gastric Suctioning Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5910 |
| Definition | The Device Is Used To Control A Patient's Temperature, While Simultaneously Maintaining Access To The Stomach To Allow Gastric Decompression And Drainage. |