Arctx Cool Catheter Set— 510(k) K250632
Substantially EquivalentArctx Medical
FDA 510(k) clearance K250632 for Arctx Cool Catheter Set, Substantially Equivalent on 2025-10-30. Applicant: Arctx Medical.
Clearance details
- Applicant
- Arctx Medical
- Product code
- Code PLA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raleigh, NC, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.