FDA product code OFD: Catheter Introducer Kit

OFD is the FDA product code for catheter introducer kit. It is a Class II device, regulated under 21 CFR 870.1340 and reviewed by the Cardiovascular panel. Devices under OFD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 7 recalls for OFD devices, 6 initiated in the last five years.

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. The 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 OFD devices

7 product recalls in 7 recall events; 6 initiated in the last five years and 5 still open. Most recent: 2026-05-21.

Frequently asked questions

What is FDA product code OFD?

OFD is the FDA product code for catheter introducer kit. It is a Class II device, regulated under 21 CFR 870.1340 and reviewed by the Cardiovascular panel.

What device class is OFD?

Class II, regulation 21 CFR 870.1340. Typical premarket route: 510(k) exempt.

Have OFD devices been recalled?

Yes: 7 product recalls across 7 recall events; the most recent began 2026-05-21.

Next steps

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