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Quantra QPlus System

by Hemosonics LLC 2 variants

510(k) K223433

Quantra QPlus System is a Class II device made by Hemosonics LLC, cleared under FDA 510(k) K223433 on 13 Dec 2022, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK223433 Date13 Dec 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QFR
FDA applicant
Hemosonics, LLC
Device class
Class II
Regulation
21 CFR Part 864.5430
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

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