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Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor

by Qura S.R.L 510(k)

Active United States Open recall

510(k) K201320

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201320 Date3 Nov 2021ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1327-2025 FDA Class II initiated 16 Jan 2025

    Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.

Specification

510(k)

510(k) Number
FDA Product Code
KFM
Device Class
Class II
Regulation
21 CFR Part 870.4360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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