FDA product code OFK: Percutaneous Atrial Catheter Kit
OFK is the FDA product code for percutaneous atrial catheter kit. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel. Devices under OFK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Percutaneous Atrial Catheter Kit |
| Device class | Class II |
| Regulation | 21 CFR 870.1250 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for OFK devices
openFDA lists no recalls for product code OFK.
Frequently asked questions
What is FDA product code OFK?
OFK is the FDA product code for percutaneous atrial catheter kit. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel.
What device class is OFK?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OFK
- Run a recall and safety report across every OFK manufacturer
- Watch product code OFK 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.