Medical Device Manufacturer · US , Warren , NJ

Cordis Corporation

13 submissions · 12 cleared · Since 2004
13
Total
12
Cleared
0
Denied

Cordis Corporation — FDA 510(k) Submissions

Cordis Corporation has submitted 13 FDA 510(k) premarket notifications since 2004, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Angioplasty, Peripheral, Transluminal, Introducer, Catheter, Catheter, Percutaneous, Catheter, Intravascular, Diagnostic, Temporary Carotid Catheter For Embolic Capture . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
K220654 · NTE Temporary Carotid... · Cardiovascular
Apr 2022 30d
SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
K212977 · DQO Catheter, Intravascular,... · Cardiovascular
Feb 2022 153d
SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
K210626 · LIT Catheter, Angioplasty,... · Cardiovascular
Apr 2021 52d
Brite Tip Radianz Guiding Sheath
K202167 · DYB Introducer, Catheter · Cardiovascular
Feb 2021 207d
SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
K201377 · LIT Catheter, Angioplasty,... · Cardiovascular
Oct 2020 136d
SABER .035 PTA Dilatation Catheter
K201333 · LIT Catheter, Angioplasty,... · Cardiovascular
Sep 2020 115d
RAIN Sheath Transradial
K181592 · DYB Introducer, Catheter · Cardiovascular
Aug 2018 58d
RAILWAY Sheathless Access System
K180081 · DYB Introducer, Catheter · Cardiovascular
Apr 2018 97d
ADROIT Guiding Catheter
K143412 · DQY Catheter, Percutaneous · Cardiovascular
Jan 2015 47d
SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER
K133843 · LIT Catheter, Angioplasty,... · Cardiovascular
Jun 2014 191d
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K121442 · LIT Catheter, Angioplasty,... · Cardiovascular
Jun 2012 30d
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K041796 · FGE Stents, Drains And... · Gastroenterology & Urology
Aug 2004 32d
CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F
K034050 · DTK Filter, Intravascular,... · Cardiovascular
Mar 2004 83d
Filters