FDA product code OFB: Catheter Guide Wire Kit

OFB is the FDA product code for catheter guide wire kit. It is a Class II device, regulated under 21 CFR 870.1330 and reviewed by the Cardiovascular panel. Devices under OFB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for OFB devices, 2 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 OFB devices

2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-04-21.

Frequently asked questions

What is FDA product code OFB?

OFB is the FDA product code for catheter guide wire kit. It is a Class II device, regulated under 21 CFR 870.1330 and reviewed by the Cardiovascular panel.

What device class is OFB?

Class II, regulation 21 CFR 870.1330. Typical premarket route: 510(k) exempt.

Have OFB devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2026-04-21.

Next steps

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