EnsoETM
FDA 510(k) clearance K172029 · decided 2018-01-05
Clearance details
- K-number
- K172029
- Device name
- EnsoETM
- Applicant
- Attune Medical
- Decision
- Substantially Equivalent
- Date received
- 2017-07-05
- Decision date
- 2018-01-05
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- PLA
- Device class
- 2
- Regulation number
- 870.5910
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Arctx Cool Catheter Set (K250632) | Arctx Medical | 2025-10-30 |
| EsoCool Thermal Regulation Catheter (K233357) | Nuvaira, Inc. | 2024-06-27 |
| EnsoETM (K180742) | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-05-17 |
| EnsoETM (K180244) | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-02-28 |
| EnsoETM (K172493) | Attune Medical | 2017-10-17 |
| Esophageal Cooling Device (K170009) | Advanced Cooling Therapy, LLC | 2017-03-30 |
| Esophageal Cooling Device (K152450) | Advanced Cooling Therapy, LLC | 2016-01-15 |
| ESOPHAGEAL COOLING DEVICE (DEN140018) | Advanced Cooling Therapy, LLC | 2015-06-23 |
Recalls involving this device
No recalls on record reference this clearance.