Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 Onset Medical Corporation with 8 510(k) clearances. The most recent is a 510(k) clearance dated Jan 5, 2016: SoloPath Re-Collapsible Access System.
| Jan 5, 2016 | SoloPath Re-Collapsible Access SystemK152498 · DYB | 510(k) clearances |
| May 3, 2013 | SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEMK121404 · DYB | 510(k) clearances |
| Oct 11, 2011 | ONSET ACCESS CATHETER SYSTEMK112629 · DQY | 510(k) clearances |
| Aug 2, 2010 | THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCERK100819 · DYB | 510(k) clearances |
| Oct 8, 2009 | SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCERK092014 · DYB | 510(k) clearances |
| Feb 23, 2007 | BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870K062852 · DYB | 510(k) clearances |
| May 2, 2006 | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUSK061009 · EZN | 510(k) clearances |
| Feb 10, 2005 | PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATHK043254 · EZN | 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
