Arctx Cool Catheter Set
FDA 510(k) clearance K250632 · decided 2025-10-30
Clearance details
- K-number
- K250632
- Device name
- Arctx Cool Catheter Set
- Applicant
- Arctx Medical
- Decision
- Substantially Equivalent
- Date received
- 2025-03-03
- Decision date
- 2025-10-30
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- PLA
- Device class
- 2
- Regulation number
- 870.5910
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Raleigh, NC, 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 |
|---|---|---|
| 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 |
| ESOPHAGEAL COOLING DEVICE (DEN140018) | Advanced Cooling Therapy, LLC | 2015-06-23 |
Recalls involving this device
No recalls on record reference this clearance.