FDA product code OBD: Barrier, Adhesion, Cardiovascular
OBD is the FDA product code for barrier, adhesion, cardiovascular. It is a Class III device, reviewed by the Cardiovascular panel. Devices under OBD reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Indicated to reduce the incidence, severity or extent of adhesions/tissue attachment in cardiovascular surgery by providing a plane of dissection or mechanical barrier between opposing surfaces of tissue and/or devices. Intended for use in cardiac surgery to prevent or reduce adhesions, and facilitate reoperation in patients who are anticipated to need staged cardiovascular surgeries or repeat procedures in the thoracic region.
Classification
| Field | Value |
|---|---|
| Device name | Barrier, Adhesion, Cardiovascular |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OBD devices
openFDA lists no recalls for product code OBD.
Frequently asked questions
What is FDA product code OBD?
OBD is the FDA product code for barrier, adhesion, cardiovascular. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is OBD?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OBD
- Run a recall and safety report across every OBD manufacturer
- Watch product code OBD 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times