Onset Medical Corporation - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Onset Medical Corporation Cardiovascular ✕
6 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