DeviceClearance

Product code PZS— Cardiovascular

MC3 Crescent Jugular Dual Lumen Catheter

Classification name
Dual Lumen Ecmo Cannula
Device class
Class 2
Regulation
21 CFR 870.4100
Advisory panel
Cardiovascular
Total cleared
4
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PZS under 21 CFR 870.4100, via openFDA

Market context for product code PZS

FDA has cleared 4 devices under product code PZS between 2017 and 2023, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PZS

Adverse events under product code PZS

product code PZS
Death
17
Total
17

Source: openFDA MAUDE database, through . 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 PZS

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