Medical Device Manufacturer · US , West Berlin , NJ

Ep Medsystems - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1996

Recent clearances: EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04, MODIFICATION TO VIEWMATE SYSTEM, VIEWMATE SYSTEM

View 12 510(k) Devices ↓

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ep Medsystems Cardiovascular ✕

9 devices

1-9 of 9

Cleared Oct 16, 2009

EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04

Cardiovascular · 24d

Cleared Apr 11, 2007

Cardiovascular · 28d

Cleared Oct 27, 2006

Cardiovascular · 16d

Cleared Sep 14, 2004

EP-4 CLINICAL STIMUTATOR

Cardiovascular · 105d

Cleared Feb 27, 2004

EP-4 CLINICAL STIMULATOR

Cardiovascular · 28d

Cleared Aug 20, 2003

EP-WORKMATE WITH RPM SYSTEM

Cardiovascular · 30d

Cleared Jul 15, 1999

MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS...

Cardiovascular · 112d

Cleared Feb 22, 1999

PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER

Cardiovascular · 95d

Cleared May 13, 1996

PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET

Cardiovascular · 24d