DeviceClearance

Product code QHW— Cardiovascular

Bio-Medicus Life Support Catheter and Introducer

Classification name
Single Lumen Ecmo Cannula
Device class
Class 2
Regulation
21 CFR 870.4100
Advisory panel
Cardiovascular
Total cleared
3
First cleared
Most recent

FDA classification 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.”

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

Market context for product code QHW

FDA has cleared 3 devices under product code QHW between 2022 and 2026, filed by 1 applicant company. 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 QHW

Recent clearances under product code QHW

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