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 Acumen Medical with 12 510(k) clearances. The most recent is a 510(k) clearance dated Feb 17, 2009: MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59.
| Feb 17, 2009 | MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59K083855 · DYB | 510(k) clearances |
| Mar 13, 2008 | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7K080500 · DYB | 510(k) clearances |
| May 22, 2007 | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45K070396 · DYB | 510(k) clearances |
| Apr 6, 2007 | ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEMK070051 · DQY | 510(k) clearances |
| Feb 23, 2007 | ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STYK070197 · DYB | 510(k) clearances |
| Aug 23, 2006 | MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90K062145 · DYB | 510(k) clearances |
| Aug 18, 2006 | 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67K062084 · DQY | 510(k) clearances |
| Jun 19, 2006 | ACUMEN SINGLE-LUMEN DELIVERY SHEATHK053400 · DYB | 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
