Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Onset Medical Corporation

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K152498 SoloPath Re-Collapsible Access SystemDYB2016-01-05 View
510(k) K121404 SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEMDYB2013-05-03 View
510(k) K112629 ONSET ACCESS CATHETER SYSTEMDQY2011-10-11 View
510(k) K100819 THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCERDYB2010-08-02 View
510(k) K092014 SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCERDYB2009-10-08 View
510(k) K062852 BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870DYB2007-02-23 View
510(k) K061009 PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUSEZN2006-05-02 View
510(k) K043254 PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATHEZN2005-02-10 View
↑