VitalStream ART Connect; VitalStream-Hemo
K-Number: K251275 · 2025-09-26
ApplicantCaretaker Medical
Decision Date2025-09-26
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
VitalStream ART Connect; VitalStream-Hemo is a medical device manufactured by Caretaker Medical. It received FDA 510(k) clearance on 2025-09-26 under approval number K251275. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VitalStream ART Connect; VitalStream-Hemo?
VitalStream ART Connect; VitalStream-Hemo is a medical device that received FDA 510(k) clearance on 2025-09-26. It is manufactured by Caretaker Medical. The 510(k) number is K251275.
When was VitalStream ART Connect; VitalStream-Hemo approved by the FDA?
VitalStream ART Connect; VitalStream-Hemo received FDA 510(k) clearance on 2025-09-26, under approval number K251275.
What company makes VitalStream ART Connect; VitalStream-Hemo?
VitalStream ART Connect; VitalStream-Hemo is manufactured by Caretaker Medical.
What is the FDA product code for VitalStream ART Connect; VitalStream-Hemo?
The FDA product code for VitalStream ART Connect; VitalStream-Hemo is DXG.
Other Devices by Caretaker Medical
Related Devices (Code: DXG)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.