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Endocardial Solutions, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K042493ENSITE SYSTEM, MODEL EE3000October 15, 2004
K033211ENSITE SYSTEMOctober 30, 2003
K030129MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000April 22, 2003
K012926MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000September 28, 2001
K001437ENSITE 3000 SYSTEM, MODEL EE3000June 7, 2000
K993376ENSTYLET MODELS EC0010, EC0020January 5, 2000
K992479ENSITE 3000 SYSTEMDecember 2, 1999
K983456ENSITE 3000 SYSTEMApril 21, 1999