Endocardial Solutions, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ENSITE 3000 SYSTEM
8
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Endocardial Solutions, Inc. Cardiovascular ✕
8 devices
Cleared
Oct 15, 2004
ENSITE SYSTEM, MODEL EE3000
Cardiovascular
31d
Cleared
Oct 30, 2003
ENSITE SYSTEM
Cardiovascular
27d
Cleared
Apr 22, 2003
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
Cardiovascular
98d
Cleared
Sep 28, 2001
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
Cardiovascular
28d
Cleared
Jun 07, 2000
ENSITE 3000 SYSTEM, MODEL EE3000
Cardiovascular
30d
Cleared
Jan 05, 2000
ENSTYLET MODELS EC0010, EC0020
Cardiovascular
90d
Cleared
Dec 02, 1999
ENSITE 3000 SYSTEM
Cardiovascular
129d
Cleared
Apr 21, 1999
ENSITE 3000 SYSTEM
Cardiovascular
203d