510(k) K152450
- Device
- Esophageal Cooling Device
- Applicant
- ADVANCED COOLING THERAPY, LLC
- 510(k) number
- K152450
- Product code
- PLA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-01-15
- Date received
- 2015-08-28
- Regulation
- 870.5910
- Classification name
- Esophageal Thermal Regulation And Gastric Suctioning Device
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Erik Kulstad
- Address
- 3440 S. Dearborn St. #215-South Chicago IL US 60616 60616
FDA Registration Numbers#
- 3003477135
- 3010412492
Source Documents#
Other 510(k) Records For Product Code PLA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250632 | Arctx Cool Catheter Set | Arctx Medical | 2025-10-30 |
| K233357 | EsoCool Thermal Regulation Catheter | Nuvaira, Inc. | 2024-06-27 |
| K180742 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-05-17 |
| K180244 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-02-28 |
| K172029 | EnsoETM | Attune Medical | 2018-01-05 |
| K172493 | EnsoETM | Attune Medical | 2017-10-17 |
| K170009 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2017-03-30 |
| DEN140018 | ESOPHAGEAL COOLING DEVICE | Advanced Cooling Therapy, LLC | 2015-06-23 |
Legacy Summary#
summary
FDA Review#
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