Data / Medical devices / Set, Administration, Intravascular

Set, Administration, Intravascular (FPA): 253 FDA-registered makers in 34 countries

253 establishments in 34 countries are registered with the FDA to make Set, Administration, Intravascular (product code FPA, Class 2, 21 CFR 880.5440). 142 of them have a 510(k) clearance or PMA approval on file and 32 have a recall event. The FDA has issued 1,176 510(k) clearances under this code, the latest on October 22, 2026, and lists 231 recall events (18 Class I). FDA data exported November 3, 2026.

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Product code

FPA

Device class

2

Regulation

880.5440

Medical specialty

General Hospital

Makers by country

Makers of Set, Administration, Intravascular

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated October 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.