PZS

Dual Lumen Ecmo Cannula

Product code

PZS

Device name

Dual Lumen Ecmo Cannula

Device class

Class 2

21 CFR

21 CFR 870.4100

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-10-06.

1 summaries are archived here for direct download.