Medical Device Manufacturer · US , Warren , NJ

Cordis Europa, N.V.

7 submissions · 5 cleared · Since 2001
7
Total
5
Cleared
0
Denied

Cordis Europa, N.V. — FDA 510(k) Submissions

Cordis Europa, N.V. has submitted 7 FDA 510(k) premarket notifications since 2001, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stents, Drains And Dilators For The Biliary Ducts, Dilator, Esophageal, Catheter, Angioplasty, Peripheral, Transluminal, Catheter, Percutaneous . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
K071189 · LIT Catheter, Angioplasty,... · Cardiovascular
May 2007 16d
CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER
K063563 · LIT Catheter, Angioplasty,... · Cardiovascular
Mar 2007 99d
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
K060302 · KNQ Dilator, Esophageal · Gastroenterology & Urology
Apr 2006 64d
INSCOPE 3-STAGE BALLOON DILATOR
K043605 · KNQ Dilator, Esophageal · Gastroenterology & Urology
Feb 2005 36d
CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K040413 · FGE Stents, Drains And... · Gastroenterology & Urology
Jun 2004 124d
CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA
K032737 · DQY Catheter, Percutaneous · Cardiovascular
Oct 2003 28d
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K012056 · FGE Stents, Drains And... · Gastroenterology & Urology
Aug 2001 30d
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