FDA Product Code
FDA Product Code PLA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5910
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250632 | Arctx Cool Catheter Set | Arctx Medical | 2025-10-30 | Traditional | PDF ↗ |
| K233357 | EsoCool Thermal Regulation Catheter | Nuvaira, Inc. | 2024-06-27 | Abbreviated | PDF ↗ |
| K180742 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-05-17 | Traditional | PDF ↗ |
| K180244 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-02-28 | Special | PDF ↗ |
| K172029 | EnsoETM | Attune Medical | 2018-01-05 | Traditional | PDF ↗ |
| K172493 | EnsoETM | Attune Medical | 2017-10-17 | Traditional | PDF ↗ |
| K170009 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2017-03-30 | Traditional | PDF ↗ |
| K152450 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2016-01-15 | Traditional | PDF ↗ |
| DEN140018 | ESOPHAGEAL COOLING DEVICE | Advanced Cooling Therapy, LLC | 2015-06-23 | Direct | — |
Product code PLA · Class II · Cardiovascular. Data: openFDA.