Product code MZQ— Neurology

DETACHABLE SILICONE BALLOON (DSB)

Classification name
Balloon, Detachable, For Neurovascular Occlusion
Device class
Class 2
Regulation
21 CFR 882.5950
Advisory panel
Neurology
Total cleared
2
First cleared
Most recent

Market context for product code MZQ

FDA has cleared 2 devices under product code MZQ, all in 1998, 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 MZQ

Recent clearances under product code MZQ

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