BECTON, DICKINSON AND COMPANY

FDA Device Registration & Listing · Irvine, CA, US · Registration 3032916632

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
3032916632
FEI Number
3032916632
Entity Name
BECTON, DICKINSON AND COMPANY
City/State/Country
Irvine, CA, US
Establishment Address
17200 Laguna Canyon Rd, Irvine, CA 92618, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Becton, Dickinson and Company (Owner Number: 10093301)
Owner / Operator Contact Address
17200 Laguna Canyon Road, Irvine, CA 92618, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K924661
PMA Number
N/A

All Registered Proprietary Names

Laparoscopic Cholangiography Catheter EDWARDS CRITICAL-CARE SWAN-GANZ Thermodilution Catheter, VIP and VIP+, True Size EOCVC Kit Edwards Oximetry Central Venous Catheter Kit HemoSphere Pressure Cable HemoSphere ClearSight Module VitaWave Plus finger cuff HemoSphere Vita Monitor HemoSphere Technology Module HemoSphere Vita Technology Module Acumen IQ Plus Finger Cuff HemoSphere Advanced Monitor Smart Pressure Controller HemoSphere VitaWave module HemoSphere Nano Monitor Edwards Vascushunt II SWAN-GANZ Fogarty SWAN-GANZ VAMP Venous/Arterial Blood Management Protection System DISPOSABLE PRESSURE DOME Dome Swan-Ganz Catheters VolumeView ClearSight finger cuff HemoSphere Advanced Monitor (HEM1) HemoSphere Swan-Ganz Module (HEMSGM10) HemoSphere Oximetry Cable (HEMOXSC100) SWAN-GANZ TruWave Disposable Pressure Transducer PreSep Edwards Peripheral Dilation Catheter HemoSphere Vita Monitor Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter HemoSphere Technology Module Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter, 5-pack HemoSphere Advanced Monitor ViewFinder Remote Acumen IQ sensor with 84” (213cm) pressure tubing, Acumen IQ fluid meter, 5-pack HemoSphere Vita Technology Module HemoSphere Pressure Cable Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult Pressure Controller Kit Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult, 5-pack HemoSphere Oximetry Cable HemoSphere ClearSight Module HemoSphere Swan-Ganz Module Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult with TruWave DPT, 5-pack HemoSphere ForeSight Oximeter Cable Acumen AFM Cable Heart Reference Sensor HemoSphere VitaWave Module Acumen IQ sensor with 84” (213cm) pressure tubing with Acumen IQ fluid meter Acumen IQ Fluid Meter Acumen Hypotension Prediction Index Acumen Assisted Fluid Management HemoSphere Swan-Ganz Module HemoSphere Technology Module HemoSphere Advanced Monitor HemoSphere Oximetry Cable HemoSphere ClearSight Module Viewfinder Remote HemoSphere Pressure Cable Fogarty VAMP Plus Venous/Arterial Blood Management Protection System Fogarty Venous Thrombectomy Catheter Thru-lumen Embolectomy catheter SWAN-GANZ HemoSphere Tissue Oximetry Module FORE-SIGHT ELITE PRE-AMP CABLE 4m and 6.5m FORE-SIGHT ELITE TISSUE OXIMETER SENSORS, ForeSight Sensors FORE-SIGHT ELITE Tissue Oximeter HemoSphere Pressure Cable Acumen Hypotension Prediction Index Feature HemoSphere Pressure-Out Cable (HEMDPT1000) HemoSphere Oximetry Cable HemoSphere Swan-Ganz Module HemoSphere Advanced Monitor Disposable Pressure Transducer TruWave™ Disposable Pressure Transducers Disposable Pressure Transducer SWAN-GANZ ClearSight and AcumenIQ finger cuffs HemoSphere ClearSight Module HemoSphere AltaTM advanced monitor (Smart Recovery) HemoSphere AltaTM advanced monitor (Cardiac) HemoSphere AltaTM advanced monitor (All-on-One) Fogarty SWAN-GANZ Continuous Cardiac Output Thermodilution Catheter SWAN-GANZ Thermodilution Catheter, VIP and VIP+, True Size Swan-Ganz Thermodilution Catheter Pressure Controller EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Pressure Controller Kit Cuffs or ClearSight System EV1000 Clinical Platform Fogarty Occlusion Catheter Fogarty Acumen IQ finger cuff Acumen IQ finger cuff adult VitaWave finger cuff adult Swan-Ganz Pacing-TD Catheter Swan-Ganz Bipolar Pacing Catheter BD Algorithm for Measurement of Blood Hemoglobin Total Blood Hemoglobin (tHb) Algorithm FloTrac Sensor FloTrac Jr Sensor Transducer, blood-pressure, extravascular VolumeView sensor Acumen IQ sensor Swan-Ganz TruClip Swan-Ganz COO/SVO2 Shear Force Gauge Swan IQ Pulmonary Arterial Catheter Swan-Ganz IQ catheter - AIQSGF8 FloTrac Jr sensor ClearSight Jr finger cuff Swan-Ganz Jr catheter HemoSphere SWAN-GANZ SWAN-GANZ Swan Ganz Catheters Fogarty SWAN-GANZ Polymer Blend True Size ControlCath Thermodilution Catheters Swan-Ganz Oximetry Catheter VASCULAR CLAMP Fogarty 6mm Spring Clip Fogarty HemoSphere Alta Advanced Monitoring Platform Patient CCO cable - HemoSphere Alta advanced monitoring platform PACEMAKER TEMPORARY ELECTRODE MHM1E MHM1 Vigileo Monitor TruWave Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts Fogarty Arterial Embolectomy Catheter Fogarty Biliary Balloon Probe Fogarty Arterial Embolectomy Catheter with Gate Valve Fogarty FusedCO Algorithm Duravess SWAN-GANZ Continuous Cardiac Output/End Diastolic Volume Thermodilution Catheter Percutaneous Sheath Introducers PreSep PreSep Oximetry Catheters Edwards Oximetry Central Venous Catheter PediaSat Oximetry Catheter TruWave Disposable Pressure Transducer PX 1800 TRUCLIP CATHETER TIP, PRESSURE TRANSDUCER VolumeView sensor FloTrac Sensor FloTrac Jr Sensor Acumen IQ sensor VAMP Venous/Arterial Blood Management Protection System ClearSight finger cuff Accumen IQ finger cuff Swan Ganz Catheters EV1000 Clinical Platform NI EV1000NI Clearsight EV1000 Non-invasive Clearsight system Clearsight finger cuff SWAN-GANZ Right Heart Ejection Fraction Thermodilution and Oximetry Catheter Swan-Ganz Continuous Cardia Output Thermodilution Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-05-06
DSF Recorder, Paper Chart Cardiovascular Class 1 870.2810 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-09-30
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2026-03-03
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-03-03
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2025-05-06
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-05-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-04-24
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2025-05-06
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-05-06
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2025-05-06
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2026-02-10
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-05-06
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2025-05-06
QMS Adjunctive Open Loop Fluid Therapy Recommender Cardiovascular Class 2 870.5600 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-05-06
QMS Adjunctive Open Loop Fluid Therapy Recommender Cardiovascular Class 2 870.5600 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-05-06
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2025-05-06
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2025-05-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-02-13
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2025-05-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-04-24
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2026-04-24
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-05-06
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2025-05-06
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2026-04-24
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2025-05-06
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2026-03-23
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2026-03-23
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2026-03-23
QNL Medium-Term Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2026-03-23
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2026-03-23
QMS Adjunctive Open Loop Fluid Therapy Recommender Cardiovascular Class 2 870.5600 2026-03-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2026-03-23
QEM Cerebral Oximeter Cardiovascular Class 2 870.2700 2026-03-23
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-03-23
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2026-03-23
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2025-05-06
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2025-05-06
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2025-05-06
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2026-04-24
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
FOX Stand, Infusion General Hospital Class 1 880.6990 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2025-05-06
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-05-06
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2025-05-06
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2025-05-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-05-06
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Gastroenterology, Urology Class 2 876.5010 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
QNL Medium-Term Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2025-05-06
QMS Adjunctive Open Loop Fluid Therapy Recommender Cardiovascular Class 2 870.5600 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-05-06
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2025-05-06
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2025-05-06
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2025-05-06
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2026-06-09
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Gastroenterology, Urology Class 2 876.5010 2025-05-06
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2025-05-06
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2025-05-06
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-05-06
PSQ Intracardiac Patch Or Pledget, Biologically Derived Cardiovascular Class 2 870.3470 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-05-06
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2025-05-06
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2025-05-06
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2025-04-28
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-02-13
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2026-02-13
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2026-04-23
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-05-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-05-06

Official Correspondent

Karen O'Leary

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Becton, Dickinson and Company
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3042941992 Edwards Lifesciences Holding B.V. AMSTERDAM Noord-Holland, NL
2648045 EDWARDS LIFESCIENCES TECHNOLOGY SARL ANASCO, PR, US
9615817 CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG HAINA San Cristobal, DO

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K924661 Baxter Healthcare Corp SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER 1993-04-08
K213616 Becton, Dickinson and Company BD Surgiphor Antimicrobial Irrigation System 2022-03-23
K902734 Olympus Corp. PR CANNULAS 1990-08-22
K770946 Instrumentation Laboratory CO RECORD, MODEL 702, I.L. 1977-07-05
K833836 Instrumentation Laboratory CO IL HEPARINIZED FLOW DIRECTED THERMAL 1984-02-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0035-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032916632. Last updated year: 2026. Please use registration number 3032916632 when referencing this establishment in official correspondence.
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