FDA product code OFA: Cardiovascular Surgical Instruments Tray

OFA is the FDA product code for cardiovascular surgical instruments tray. It is a Class I device, regulated under 21 CFR 870.4500 and reviewed by the Cardiovascular panel. Devices under OFA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 21 recalls for OFA devices.

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

Recalls for OFA devices

21 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-01-07.

Frequently asked questions

What is FDA product code OFA?

OFA is the FDA product code for cardiovascular surgical instruments tray. It is a Class I device, regulated under 21 CFR 870.4500 and reviewed by the Cardiovascular panel.

What device class is OFA?

Class I, regulation 21 CFR 870.4500. Typical premarket route: 510(k) exempt.

Have OFA devices been recalled?

Yes: 21 product recalls across 6 recall events; the most recent began 2016-01-07.

Next steps

• Run an FDA pathway report with predicate devices for product code OFA
• Run a recall and safety report across every OFA manufacturer
• Watch product code OFA 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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