FDA product code NPE: Material, Embolization, Neurovascular, Polymerizing Or Precipitating

NPE is the FDA product code for material, embolization, neurovascular, polymerizing or precipitating. It is a Class III device, reviewed by the Neurology panel. Devices under NPE reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for NPE devices.

Definition

This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation. It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ. Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations.

Classification

Recalls for NPE devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-01.

Frequently asked questions

What is FDA product code NPE?

NPE is the FDA product code for material, embolization, neurovascular, polymerizing or precipitating. It is a Class III device, reviewed by the Neurology panel.

What device class is NPE?

Class III. Typical premarket route: PMA.

Have NPE devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2017-05-01.

Next steps

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