FDA 510(k) Applications Submitted by ONSET MEDICAL CORPORATION

FDA 510(k) Number	Submission Date	Device Name	Applicant
K092014	07/06/2009	SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER	ONSET MEDICAL CORPORATION
K061009	04/12/2006	PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS	ONSET MEDICAL CORPORATION
K062852	09/25/2006	BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870	ONSET MEDICAL CORPORATION
K043254	11/24/2004	PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH	ONSET MEDICAL CORPORATION
K100819	03/23/2010	THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER	ONSET MEDICAL CORPORATION
K121404	05/10/2012	SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM	ONSET MEDICAL CORPORATION
K112629	09/09/2011	ONSET ACCESS CATHETER SYSTEM	ONSET MEDICAL CORPORATION
K152498	09/01/2015	SoloPath Re-Collapsible Access System	ONSET MEDICAL CORPORATION