Medical Device Manufacturer · US , Mountain View , CA

Ep Technologies, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1988

Recent clearances: REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM, ASTRONOMER PLUS SYSTEM, POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D

View 15 510(k) Devices ↓

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ep Technologies, Inc. Cardiovascular ✕

15 devices

1-12 of 15

Cleared Feb 03, 2005

REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM

Cardiovascular · 71d

Cleared Apr 09, 2002

ASTRONOMER PLUS SYSTEM

Cardiovascular · 182d

Cleared Dec 07, 2000

POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D

Cardiovascular · 30d

Cleared Aug 02, 1994

DIAGNOSTIC I CATHETER

Cardiovascular · 207d

Cleared Jul 27, 1994

DIAGNOSTIC II CATHETER

Cardiovascular · 201d

Cleared Dec 16, 1993

Cardiovascular · 489d

Cleared Dec 16, 1993

Cardiovascular · 489d

Cleared Oct 25, 1991

TORQUE TUBE STEEROCATH(TM)

Cardiovascular · 88d

Cleared Oct 12, 1990

FRANZ(TM) STEERABLE COMBINATION CATHETER

Cardiovascular · 51d

Cleared May 07, 1990

Cardiovascular · 80d

Cleared Mar 14, 1990

QUATTRO CATHETER

Cardiovascular · 43d

Cleared Mar 13, 1990

CONSTANT CURRENT STIMULATOR MODEL 022101

Cardiovascular · 35d