K250632
- 510(k) number
- K250632
- Device name
- Arctx Cool Catheter Set
- Applicant
- Arctx Medical NC · US
- Product code
- PLA — Esophageal Thermal Regulation And Gastric Suctioning
- Decision date
- 2025-10-30
- Date received
- 2025-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250632.pdf
Official FDA record: K250632
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.