FDA device listing
ensoETM
FDA device listing 1710960611 · Advanced Cooling Therapy, LLC d/b/a "Attune Medical"
Key facts
| Proprietary names | ensoETM |
|---|---|
| Owner/operator | Advanced Cooling Therapy, LLC d/b/a "Attune Medical" |
| Owner/operator number | 10044486 |
| Premarket submissions | DEN230021 |
| Product codes | PLA, QXV |
| Device names | PLA - Esophageal Thermal Regulation And Gastric Suctioning Device, QXV - Temperature Regulation Device For Esophageal Protection During Cardiac Ablation |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.5720, 870.5910 |
| Review panels | Cardiovascular |
| Registered establishments | Advanced Cooling Therapy, LLC |
| Establishment registrations | 3010412492 |
| FEI numbers | 3010412492 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database