Quantra QPlus System
K-Number: K201513 · 2020-08-21
ApplicantHemosonics, LLC
Decision Date2020-08-21
Product CodeQFR
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
Quantra QPlus System is a medical device manufactured by Hemosonics, LLC. It received FDA 510(k) clearance on 2020-08-21 under approval number K201513. 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 QPlus System?
Quantra QPlus System is a medical device that received FDA 510(k) clearance on 2020-08-21. It is manufactured by Hemosonics, LLC. The 510(k) number is K201513.
When was Quantra QPlus System approved by the FDA?
Quantra QPlus System received FDA 510(k) clearance on 2020-08-21, under approval number K201513.
What company makes Quantra QPlus System?
Quantra QPlus System is manufactured by Hemosonics, LLC.
What is the FDA product code for Quantra QPlus System?
The FDA product code for Quantra QPlus System is QFR.
Related Clinical Trials
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.