VitalStream ART Connect; VitalStream-Hemo— 510(k) K251275

Name: FDA 510(k) clearance K251275
Creator: U.S. Food and Drug Administration
Published: 2025-09-26

Substantially Equivalent

Caretaker Medical

FDA 510(k) clearance K251275 for VitalStream ART Connect; VitalStream-Hemo, Substantially Equivalent on 2025-09-26. Applicant: Caretaker Medical. Device class: 2.

Clearance details

Applicant: Caretaker Medical
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2025-04-24
Decision date: 2025-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, US

Download summary PDF View on FDA.gov ↗

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