QNR

LifeSPARC System

Advisory panel: Cardiovascular
Total cleared: 8

Adverse events under product code QNR

product code QNR

Death: 11
Total: 11

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QNR

K250199 — VitalFlow Console Medtronic, Inc. · 2025-05-20
K234118 — CentriMag Acute Circulatory Support System ABBOTT MEDICAL · 2024-01-26
K233736 — LifeSPARC System Cardiacassist, Inc. · 2024-01-19
K223898 — VitalFlowTM Centrifugal Pump Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · 2023-08-25
K230364 — VitalFlow Console Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · 2023-08-25
K222038 — CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System Abbott (Formerly Thoratec Corporation) · 2022-12-08
K211830 — LifeSPARC System Cardiacassist, Inc. · 2022-11-15
K202751 — TandemHeart Pump and Escort Controller Cardiacassist, Inc. · 2021-03-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.