DeviceClearance

Product code QWF— Cardiovascular

Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface

Classification name
Tubing, Long Term Support Greater Than 6 Hours
Device class
Class 2
Regulation
21 CFR 870.4100
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.”

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

Market context for product code QWF

FDA has cleared 1 device under product code QWF, all in 2023, 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.

Top applicants under product code QWF

Recent clearances under product code QWF

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