Aptus Endosystems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH, APTUS HELI-FX AORTIC SECUREMENT SYSTEM, APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
4
Total
3
Cleared
1
Denied
FDA 510(k) Regulatory Record - Aptus Endosystems, Inc. Cardiovascular ✕
4 devices
Cleared
Feb 06, 2014
APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH
Cardiovascular
30d
Cleared
Apr 12, 2013
APTUS HELI-FX AORTIC SECUREMENT SYSTEM
Cardiovascular
30d
Cleared
Aug 08, 2012
APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
Cardiovascular
113d
Not Cleared
Nov 21, 2011
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH...
Cardiovascular
342d