FDA product code OBC: Occluder, Internal Vessel, Temporary
OBC is the FDA product code for occluder, internal vessel, temporary. It is a Class III device, reviewed by the Cardiovascular panel. Devices under OBC reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 18 recalls for OBC devices.
Definition
For temporarily occluding vessels during anastomosis procedures.
Classification
| Field | Value |
|---|---|
| Device name | Occluder, Internal Vessel, Temporary |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OBC devices
18 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-06-21.
Frequently asked questions
What is FDA product code OBC?
OBC is the FDA product code for occluder, internal vessel, temporary. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is OBC?
Class III. Typical premarket route: PMA.
Have OBC devices been recalled?
Yes: 18 product recalls across 1 recall events; the most recent began 2013-06-21.
Next steps
- Run an FDA pathway report with predicate devices for product code OBC
- Run a recall and safety report across every OBC manufacturer
- Watch product code OBC 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.