Medical Device Manufacturer · US , Warren , NJ

Cordis Europa, N.V. - FDA 510(k) Cleared Devices

7 submissions · 5 cleared · Since 2001

Recent clearances: CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER, CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED

7

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cordis Europa, N.V. Cardiovascular ✕

3 devices

1-3 of 3

Cleared May 16, 2007

CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER

Cardiovascular · 16d

Cleared Mar 07, 2007

CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION...

Cardiovascular · 99d

Cleared Oct 02, 2003

CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA...

Cardiovascular · 28d