FDA product code HBZ: Catheter, Intravascular Occluding
HBZ is the FDA product code for catheter, intravascular occluding. It is a Class III device, regulated under 21 CFR 882.5150 and reviewed by the Neurology panel. Devices under HBZ reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 12/26/96 (61 FR 50708 (9/27/96))
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Intravascular Occluding |
| Device class | Class III |
| Regulation | 21 CFR 882.5150 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | PMA |
Recalls for HBZ devices
openFDA lists no recalls for product code HBZ.
Frequently asked questions
What is FDA product code HBZ?
HBZ is the FDA product code for catheter, intravascular occluding. It is a Class III device, regulated under 21 CFR 882.5150 and reviewed by the Neurology panel.
What device class is HBZ?
Class III, regulation 21 CFR 882.5150. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HBZ
- Run a recall and safety report across every HBZ manufacturer
- Watch product code HBZ 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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