Arctx Cool Catheter Set— 510(k) K250632

Substantially Equivalent

Arctx Medical

FDA 510(k) clearance K250632 for Arctx Cool Catheter Set, Substantially Equivalent on 2025-10-30. Applicant: Arctx Medical. Device class: 2.

Clearance details

Applicant: Arctx Medical
Product code: Code PLA
Device class: Class 2
Regulation: 21 CFR 870.5910
Advisory panel: Cardiovascular
Date received: 2025-03-03
Decision date: 2025-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.