Data / Medical devices / Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (LJS): 58 FDA-registered makers in 10 countries

58 establishments in 10 countries are registered with the FDA to make Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (product code LJS, Class 2, 21 CFR 880.5970). 33 of them have a 510(k) clearance or PMA approval on file and 12 have a recall event. The FDA has issued 303 510(k) clearances under this code, the latest on October 9, 2026, and lists 78 recall events (3 Class I). FDA data exported November 2, 2026.

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Product code

LJS

Device class

2

Regulation

880.5970

Medical specialty

General Hospital

Implant

Yes

Makers by country

Makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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 9, 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.