Dual Lumen Ecmo Cannula

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

Classification

FDA Product Code: PZS
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

Long term support greater than 6 hours for acute respiratory 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: 4
Registered establishments: 4

Source

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