Onset Medical Corporation is one of 16087 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Onset Medical Corporation - FDA 510(k) Cleared Devices
Recent clearances: SoloPath Re-Collapsible Access System, SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM, ONSET ACCESS CATHETER SYSTEM
8
Total
8
Cleared
0
Denied
Onset Medical Corporation has 8 FDA 510(k) cleared medical devices. Based in Mission Viejo, US.
Historical record: 8 cleared submissions from 2005 to 2016. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Onset Medical Corporation Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Regulatory Technology Services, LLC and Terumo Corporation.
FDA 510(k) Regulatory Record - Onset Medical Corporation
8 devices
Cleared
Jan 05, 2016
SoloPath Re-Collapsible Access System
Cardiovascular
126d
Cleared
May 03, 2013
SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
Cardiovascular
358d
Cleared
Oct 11, 2011
ONSET ACCESS CATHETER SYSTEM
Cardiovascular
32d
Cleared
Aug 02, 2010
THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
Cardiovascular
132d
Cleared
Oct 08, 2009
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
Cardiovascular
94d
Cleared
Feb 23, 2007
BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
Cardiovascular
151d
Cleared
May 02, 2006
PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
Gastroenterology & Urology
20d
Cleared
Feb 10, 2005
PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
Gastroenterology & Urology
78d