Cardiac Catheterization 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.

What Is FDA Product Code OES?

Cardiac Catheterization Kit is FDA product code OES, Class 2, 21 CFR 870.1200.

How Does It Reach the US Market?

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 93 recalls under this product code since 2018. None was by a company in China. 13 are Class I, the most serious grade.

The root causes the FDA records most often are Process control (23), Nonconforming Material/Component (14) and Device Design (6). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.