FDA product code OFL: Percutaneous Sheath Introducer Kit

OFL is the FDA product code for percutaneous sheath introducer kit. It is a Class II device, regulated under 21 CFR 870.1340 and reviewed by the Cardiovascular panel. Devices under OFL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 5 recalls for OFL devices, 5 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. 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 OFL devices

5 product recalls in 4 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-04-21.

Frequently asked questions

What is FDA product code OFL?

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

What device class is OFL?

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

Have OFL devices been recalled?

Yes: 5 product recalls across 4 recall events; the most recent began 2026-04-21.

Next steps

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