Quantra QPlus System
K-Number: K223433 · 2022-12-13
Device Summary
Frequently Asked Questions
What is the Quantra QPlus System?
Quantra QPlus System is a medical device that received FDA 510(k) clearance on 2022-12-13. The listed applicant is Hemosonics, LLC. The 510(k) number is K223433.
When did Quantra QPlus System receive FDA 510(k) clearance?
Quantra QPlus System received FDA 510(k) clearance on 2022-12-13, under 510(k) number K223433.
Who is the listed applicant for Quantra QPlus System?
The FDA 510(k) record lists Hemosonics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Quantra QPlus System?
The FDA product code for Quantra QPlus System is QFR.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Hemosonics, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: QFR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.