MZQ — Balloon, Detachable, For Neurovascular Occlusion Class II

FDA Device Classification

FDA product code MZQ covers "Balloon, Detachable, For Neurovascular Occlusion", a Class II medical device regulated under 21 CFR 882.5950. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MZQ
Device Class
Class II
Regulation Number
882.5950
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K965071target therapeuticsDETACHABLE SLICONE BALLOON (DSB)April 21, 1998
K964488target therapeuticsDETACHABLE SILICONE BALLOON (DSB)April 21, 1998