FDA product code MZQ: Balloon, Detachable, For Neurovascular Occlusion
MZQ is the FDA product code for balloon, detachable, for neurovascular occlusion. It is a Class II device, regulated under 21 CFR 882.5950 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under MZQ. The average 510(k) review took 508 days (median 508).
Classification
| Field | Value |
|---|---|
| Device name | Balloon, Detachable, For Neurovascular Occlusion |
| Device class | Class II |
| Regulation | 21 CFR 882.5950 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every MZQ clearance
Top MZQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Target Therapeutics | 2 | 1998-04-21 |
Most recent MZQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K965071 | Target Therapeutics | DETACHABLE SLICONE BALLOON (DSB) | 1998-04-21 | 488 |
| K964488 | Target Therapeutics | DETACHABLE SILICONE BALLOON (DSB) | 1998-04-21 | 529 |
Recalls for MZQ devices
openFDA lists no recalls for product code MZQ.
Frequently asked questions
What is FDA product code MZQ?
MZQ is the FDA product code for balloon, detachable, for neurovascular occlusion. It is a Class II device, regulated under 21 CFR 882.5950 and reviewed by the Neurology panel.
What device class is MZQ?
Class II, regulation 21 CFR 882.5950. Typical premarket route: 510(k).
How long does a 510(k) take for product code MZQ?
Across 2 cleared submissions the average was 508 days from receipt to decision (median 508).
Which companies have the most MZQ clearances?
Target Therapeutics (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MZQ
- Run a recall and safety report across every MZQ manufacturer
- Watch product code MZQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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