FDA product code OES: Cardiac Catheterization Kit

OES is the FDA product code for cardiac catheterization kit. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel. Devices under OES reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 93 recalls for OES devices, 75 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 OES devices

93 product recalls in 51 recall events; 75 initiated in the last five years and 75 still open. Most recent: 2026-08-10.

Frequently asked questions

What is FDA product code OES?

OES is the FDA product code for cardiac catheterization kit. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel.

What device class is OES?

Class II, regulation 21 CFR 870.1200. Typical premarket route: 510(k) exempt.

Have OES devices been recalled?

Yes: 93 product recalls across 51 recall events; the most recent began 2026-08-10.

Next steps

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