PLA — Esophageal Thermal Regulation And Gastric Suctioning Device Class II
FDA product code PLA covers "Esophageal Thermal Regulation And Gastric Suctioning Device", a Class II medical device regulated under 21 CFR 870.5910. Submissions are reviewed by the Cardiovascular panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PLA
- Device Class
- Class II
- Regulation Number
- 870.5910
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250632 | Arctx Medical | Arctx Cool Catheter Set | Oct 30, 2025 |
| K233357 | Nuvaira | EsoCool Thermal Regulation Catheter | Jun 27, 2024 |
| K180742 | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | EnsoETM | May 17, 2018 |
| K180244 | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | EnsoETM | Feb 28, 2018 |
| K172029 | Attune Medical | EnsoETM | Jan 5, 2018 |
| K172493 | Attune Medical | EnsoETM | Oct 17, 2017 |
| K170009 | Advanced Cooling Therapy | Esophageal Cooling Device | Mar 30, 2017 |
| K152450 | Advanced Cooling Therapy | Esophageal Cooling Device | Jan 15, 2016 |
| DEN140018 | Advanced Cooling Therapy | ESOPHAGEAL COOLING DEVICE | Jun 23, 2015 |