Cordis US Corp.

FDA Device Registration & Listing · Miami Lakes, FL, US · Registration 1016427

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1016427
FEI Number
1016427
Entity Name
Cordis US Corp.
City/State/Country
Miami Lakes, FL, US
Establishment Address
14201 N.W. 60TH AVE., Miami Lakes, FL 33014, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Cordis US Corp. (Owner Number: 1016427)
Owner / Operator Contact Address
5452 Betsy Ross Drive, --, Santa Clara, CA 95054, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K230704
PMA Number
N/A

All Registered Proprietary Names

7F & 8F High Flow Diagnostic Catheter SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter Vassallo GT Crossing14 ATW Marker Wire Steerable Guidewire ANGIOGUARD XP and ANGIOGUARD RX Emboli Capture Guidewire AVANTI+ Catheter Sheath Introducer S.M.A.R.T. Flex Biliary Self-Expanding Stent System VASSALLO GT 018 Floppy Peripheral Guide Wire Emerald Guidewire Palmaz Genesis Transhepatic Biliary Stent ADROIT Guiding Catheter Cordis BRITECROSS Support Catheter SABER® 18 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter VASSALLO GT EXT Vista Brite Tip Catheters Smart Stent RAILWAY™ Sheathless Access System INFINITI AMBI Diagnostic Catheter PALMAZ GENESIS Peripheral Stent on OPTA PRO 35" Delivery System OUTBACK® Elite Re-Entry Catheter OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter VASSALLO GT Hybrid Guide Wire 6F Super Torque Plus Diagnostic Catheter 4F Super Torque Diagnostic Catheter 5.2F Super Torque Plus Diagnostic Catheter 6F Super Torque Diagnostic Catheter Palmaz Genesis Transhepatic Biliary Stent on Slalom Delivery System Vista Brite Tip Catheters 9F Envoy Guiding Catheter SABER 14 PTA Dilatation Catheter SABERX 14 PTA Dilatation Catheter SABER™ 35 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter Modification to Smart Control CORPAC - Cardiovascular Procedure Kit PROPAC Diagnostic Procedural System PRIMOPAC - Cardiovascular Procedure Kit S.M.A.R.T. RADIANZ Vascular Stent System S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System VASSALLO GT 018 G12; VASSALLO GT 018 G30 Slalom Thrill PTA Catheter Vista Brite Tip Guiding Catheters Introducer Guide Vista Brite Tip Catheters Vessel Dilator VASSALLO GT 018 Hybrid Trapease Permanent Vena Cava Filter Palmaz Genesis Transhepatic Biliary Stent on Slalom18 Delivery System Biopsy Forceps Brite Tip Sheath Introducer Brite Tip Catheter Sheath Introduce Cordis EXOSEAL Vascular Closure Device Angiographic Catheter Extension ANGIOGRAPHIC CATHETERIZATION SET Storq Steerable Guidewire Marker Wire Steerable Guidewire (Stabilizer & WIZDOM with Radiopaque Markers) S.M.A.R.T. Flex Vascular Stent System RAIN Sheath Transradial S.M.A.R.T.® ControlTM Nitinol Stent System Palmaz Genesis Transhepatic Biliary Stent Palmaz XL Transhepatic Biliary Stent System Avanti Trans-radial sheath introducer kit Palmaz Blue 18 Transhepatic biliary System PALMAZ® Angiographic Catheters 4F Tempo Aqua Diagnostic Catheter Envoy and Vista Brite Tip ( modification) Powerflex Extreme Powerflex P3 Percutaneous Transluminal Angioplasty (PTA) Catheter OPTA Pro Percutaneous Transluminal Angioplasty (PTA) Catheter Palmaz Genesis Transhepatic Biliary Stent and Delivery System Powerflex Pro Percutaneous Transluminal Angioplasty Catheter Optease Vena Cava Filter PALMAZ MULLINS XD Pulmonary Stent Maxi LD Large Diameter Balloon Dilatation Catheter Biopsy Foceps 5F & 6F Infiniti Diagnostic Catheter Envoy & Vista Brite Tip AQUATRACK® Hydrophilic Nitinol Guidewire Mynx Control Vascular Closure Device MynxGrip Vascular Closure Device MYNX CONTROL™ Venous Vascular Closure Device 6F-12F SV Steerable Guidewire Palmaz Genesis Transhepatic Biliary Stent (modification) Trapease Permanent Vena Cava Filter Maxi LD Wizdom Extra Support with Markers Wizdom Extra Support Guidewire Stabilizer Support Guidewire Steerable Guidewire Shinobi Plus Steerable Guidewire ATW All Track Wire Steerable Guidewire Wizdom Steerable Guidewire with Markers Stabilizer Plus Steerable Guidewire Shinobi Steerable Guidewire Stabilizer Balance Performance Steerable Guidewire Wizdom Steerable Guidewire RAIN Sheath™ Tibial Pedal Introducer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2011-12-05
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2022-01-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-01-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-12-05
NTE Temporary Carotid Catheter For Embolic Capture Cardiovascular Class 2 870.1250 2022-04-07
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2006-03-16
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-06-10
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-05-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-09-08
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-05
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-06-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-07-08
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-06-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-05-25
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-05-09
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2024-02-14
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-05-23
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2015-05-07
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2014-06-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-05-25
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-04
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-02-27
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2022-04-07
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-06
OEZ Cardiovascular Procedure Kit Cardiovascular Class 2 870.1200 2024-03-14
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2012-12-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-01-02
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-07-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-12-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-05-25
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2011-12-05
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-01-20
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-06
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2008-11-17
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-12-04
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-12-04
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2011-05-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-01-09
OES Cardiac Catheterization Kit Cardiovascular Class 2 870.1200 2024-03-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-06-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-12-05
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2014-06-09
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-08-28
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2016-07-27
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-05
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-05
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-12-04
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-06
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2019-03-18
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2016-08-02
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2007-12-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2024-07-25
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2012-05-14
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2011-12-06
QWC Pulmonary Stent Unknown Class 3 N/A 2024-10-09
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2011-12-06
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2011-12-05
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-09-17
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2022-07-26
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-12-05
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-05
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2011-12-06
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2009-11-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-12-05
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-04-26

Official Correspondent

Linda Ruedy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cordis US Corp.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004939290 Cordis US Corp. Santa Clara, CA, US
9616099 Cardinal Health Mexico 244 S de RL de CV Ciudad Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K151126 Colibri Technologies, Inc. Foresight Intracardiac Echocardiography (ICE) System 2015-12-18
K931629 Carapace, Inc. CARAPACE ANGIOGRAPHY TRAYS 1993-12-06
K823758 Access Devices, Inc. CENTRAL VEIN CATHERIZATION KIT 1983-02-23
K192019 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 2019-11-08
K230411 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter 2023-04-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0008-05 N/A 2
Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011 Navilyst Medical, Inc 2
Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1016427. Last updated year: 2026. Please use registration number 1016427 when referencing this establishment in official correspondence.
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