Single Lumen Ecmo Cannula

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

Classification

FDA Product Code: QHW
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: N
Implant: N
Third-party review: N

Definition

Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use 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: 3
Registered establishments: 5

Source

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