Evalve, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST, EVALVE STEERABLE GUIDE CATHETER, EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Evalve, Inc. Cardiovascular ✕
4 devices
Cleared
Apr 21, 2010
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
Cardiovascular
30d
Cleared
Jan 13, 2010
EVALVE STEERABLE GUIDE CATHETER
Cardiovascular
27d
Cleared
Jul 02, 2009
EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
Cardiovascular
30d
Cleared
CT
Apr 27, 2009
STEERABLE GUIDE CATHETER
Cardiovascular
126d