ESOPHAGEAL COOLING DEVICE
FDA 510(k) clearance DEN140018 · decided 2015-06-23
Clearance details
- K-number
- DEN140018
- Device name
- ESOPHAGEAL COOLING DEVICE
- Applicant
- Advanced Cooling Therapy, LLC
- Decision
- Unknown
- Date received
- 2014-05-09
- Decision date
- 2015-06-23
- Days to decision
- 410 days
- Clearance type
- Direct
- 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
+ Add to Predicate Builder ◉ Watch Advanced Cooling Therapy
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K172029) | Attune Medical | 2018-01-05 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.