Ep Technologies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K043257REAL-TIME POSITION MANAGEMENT (RPM) SYSTEMFebruary 3, 2005
K013349ASTRONOMER PLUS SYSTEMApril 9, 2002
K003452POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006DDecember 7, 2000
K940167DIAGNOSTIC I CATHETERAugust 2, 1994
K940168DIAGNOSTIC II CATHETERJuly 27, 1994
K924109STEEROCATH IIDecember 16, 1993
K924108TRACFINDER IIDecember 16, 1993
K913375TORQUE TUBE STEEROCATH(TM)October 25, 1991
K903880FRANZ(TM) STEERABLE COMBINATION CATHETEROctober 12, 1990
K900765STEEROCATH(TM)May 7, 1990
K900452QUATTRO CATHETERMarch 14, 1990
K900553CONSTANT CURRENT STIMULATOR MODEL 022101March 13, 1990
K892207FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIEDJune 12, 1989
K885252MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001January 13, 1989
K881853FRANZ CATHETERJuly 18, 1988