Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

QNR · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.4100

Classification

FDA Product Code: QNR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.4100
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: Y
Implant: N
Third-party review: N

Definition

A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

Market data

Cleared 510(k) submissions: 8
Registered establishments: 9

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown