FDA product code PTU: Catheter, Peritoneal, Long-Term Indwelling, Exempt

PTU is the FDA product code for catheter, peritoneal, long-term indwelling, exempt. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel. Devices under PTU reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Definition

This product code is the class II exempt counterpart of FJS, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

Classification

Recalls for PTU devices

openFDA lists no recalls for product code PTU.

Frequently asked questions

What is FDA product code PTU?

PTU is the FDA product code for catheter, peritoneal, long-term indwelling, exempt. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel.

What device class is PTU?

Class II, regulation 21 CFR 876.5630. Typical premarket route: 510(k) exempt.

Next steps

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