FDA product code OFJ: Lead Introducer Kit
OFJ is the FDA product code for lead introducer kit. It is a Class II device, regulated under 21 CFR 870.1340 and reviewed by the Cardiovascular panel. Devices under OFJ 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 | Lead Introducer Kit |
| Device class | Class II |
| Regulation | 21 CFR 870.1340 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for OFJ devices
openFDA lists no recalls for product code OFJ.
Frequently asked questions
What is FDA product code OFJ?
OFJ is the FDA product code for lead introducer kit. It is a Class II device, regulated under 21 CFR 870.1340 and reviewed by the Cardiovascular panel.
What device class is OFJ?
Class II, regulation 21 CFR 870.1340. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OFJ
- Run a recall and safety report across every OFJ manufacturer
- Watch product code OFJ 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.