DeviceClearance

Product code QZU— Cardiovascular

BraidE Embolization Assist Device

Classification name
Temporary Embolization Assist Device, Peripheral
Device class
Class 2
Regulation
21 CFR 870.3325
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.”

— U.S. Food and Drug Administration, device classification record for product code QZU under 21 CFR 870.3325, via openFDA

Market context for product code QZU

FDA has cleared 1 device under product code QZU, all in 2024, 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 QZU

Recent clearances under product code QZU

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