Quantra QStat Cartridge
K-Number: K251404 · 2025-08-25
ApplicantHemosonics, LLC
Decision Date2025-08-25
Product CodeQFR
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
Quantra QStat Cartridge is a medical device manufactured by Hemosonics, LLC. It received FDA 510(k) clearance on 2025-08-25 under approval number K251404. The device is classified under product code QFR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Quantra QStat Cartridge?
Quantra QStat Cartridge is a medical device that received FDA 510(k) clearance on 2025-08-25. It is manufactured by Hemosonics, LLC. The 510(k) number is K251404.
When was Quantra QStat Cartridge approved by the FDA?
Quantra QStat Cartridge received FDA 510(k) clearance on 2025-08-25, under approval number K251404.
What company makes Quantra QStat Cartridge?
Quantra QStat Cartridge is manufactured by Hemosonics, LLC.
What is the FDA product code for Quantra QStat Cartridge?
The FDA product code for Quantra QStat Cartridge is QFR.
Other Devices by Hemosonics, LLC
Related Devices (Code: QFR)
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.