Percutaneous Sheath Introducer Kit

What Is This Device?

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.

How Is OFL Classified?

Percutaneous Sheath Introducer Kit is FDA product code OFL, Class 2, 21 CFR 870.1340.

What Does It Take to Sell It in the United States?

The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.

What Has Gone Wrong With It?

The FDA has recorded 5 recalls under this product code since 2022. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Process control (3), Packaging process control (1) and Nonconforming Material/Component (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.