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Data / Medical devices / Port & Catheter, Implanted, Subcutaneous, Intraventricular

Port & Catheter, Implanted, Subcutaneous, Intraventricular (LKG): 3 FDA-registered makers in 2 countries

3 establishments in 2 countries are registered with the FDA to make Port & Catheter, Implanted, Subcutaneous, Intraventricular (product code LKG, Class 2, 21 CFR 882.5550). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on May 9, 1995, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
LKG
Device class
2
Regulation
882.5550
Medical specialty
Neurology
Implant
Yes

Makers by country

CountryMakers
United States2
Dominican Republic1

Makers of Port & Catheter, Implanted, Subcutaneous, Intraventricular

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer3February 11, 1988000api.fda.gov
Natus Medical IncorporatedSan Diego, CA, United StatesComplaint file establishment, Specification developer1May 9, 1995000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicContract manufacturer0000api.fda.gov

Updated May 9, 1995. 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.