K250632 is an FDA 510(k) clearance for the Arctx Cool Catheter Set. This device is classified as a Esophageal Thermal Regulation And Gastric Suctioning Device (Class II - Special Controls, product code PLA).
Submitted by Arctx Medical (Raleigh, US). The FDA issued a Cleared decision on October 30, 2025, 241 days after receiving the submission on March 3, 2025.
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 | K250632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2025 |
| Decision Date | October 30, 2025 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| 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. |