Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Lumen Biomedical with 5 510(k) clearances. The most recent is a 510(k) clearance dated Aug 17, 2011: FIBERNET EMBOLIC PROTECTION DEVICE.
| Aug 17, 2011 | FIBERNET EMBOLIC PROTECTION DEVICEK111987 · NTE | 510(k) clearances |
| Nov 18, 2008 | FIBERNET EMBOLIC PROTECTION SYSTEMK082348 · NTE | 510(k) clearances |
| Oct 2, 2008 | LBI EMBOLECTOMY SYSTEMK080901 · QEW | 510(k) clearances |
| Aug 10, 2007 | XTRACT CATHETER SYSTEMK071529 · QEZ | 510(k) clearances |
| Jun 30, 2006 | LBI CATHETER SYSTEMK053372 · QEZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
