Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2020394

FEI Number

2020394

Entity Name

BARD PERIPHERAL VASCULAR, INC.

City/State/Country

TEMPE, AZ, US

Establishment Address

1625 W 3rd St, TEMPE, AZ 85281, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

C. R. Bard, Inc. (Owner Number: 2212754)

Owner / Operator Contact Address

1 Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K110409

PMA Number

N/A

All Registered Proprietary Names

Crosser iQ CTO Recanalization System 125 Implant Seeds BrachySource Seed Implants ESU-1 Electrosurgical Generator GlidePath 7.5F Long-Term Hemodialysis Catheter EnCor Breast Biopsy Probe with Rinse Tube 10G EnCor Breast Biopsy Probe with Rinse Tube 7G EnCor Breast Biopsy Probe with Rinse Tube 7G Vertical EnCor Breast Biopsy Probe with Rinse Tube 12G EnCor Breast Biopsy Probe with Rinse Tube 10G Vertical EnCor Breast Biopsy Probe with Rinse Tube 12G Vertical Flair Endovascular Stent Graft Soft Tissue Biopsy Drug Free Tray Jamshidi Menghini Soft Tissue Biopsy Needle/Syringe Economy Illinois Sternal/lliac Bone Marrow Aspiration Tray Safety Soft Tissue Biopsy Tray Economy Soft Tissue Biopsy Tray Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle Soft Tissue Biopsy Tray Jamshidi Bone Marrow Biopsy/Aspiration Needle Jamshidi Menghini Soft Tissue Biopsy Tray Bard Sauvage Filamentous Fabric Peripheral Vascular (PV) Sheath Tunneler Sterilization Cassette Arteriovenous (AV) Sheath Tunneler Sterilization Cassette Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Vida BAV Balloon Valvuloplasty Catheter Vida PTV Dilatation Catheter Conquest 40 PTA Dilatation Catheter Atlas Gold PTA Dilatation Catheter Distaflo Bypass Graft Simon Nitinol Vena Cava Filter Rotarex Atherectomy System Dorado PTA Balloon Catheter UltraClip II Tissue Marker E-Luminexx Vascular Stent System LifeStar Vascular Stent System Jamshidi Bone Marrow Biopsy and Aspiration Tray T-Handle Jamshidi Bone Marrow Biopsy/Aspiration Needle Instrument, biopsy Jamshidi Bone Marrow Biopsy/Aspiration Needle Jamshidi Evolve Bone Marrow Biopsy and Aspiration Trays Safe-T PLUS Trays Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Trays Venclose EVSRF Catheter Venclose digiRF Generator EnCor Breast Biopsy System - EnCor Probes, Drivers, and Accessories EnCor Breast Biopsy System FlowMate Injector Bard Parsonnet Pulse Generator Pouch (Small, Large, X-Large) DuaLok Breast Lesion Localization Wire Ghiatas Beaded Breast Localization Wire Bard Magnum Reusable Core Biopsy Instrument Gel Mark UltraCor Biopsy Site Markers Atlas Gold PTA Dilatation Catheter TruGuide Coaxial Biopsy Needles Bard TruGuide Disposable Coaxial Biopsy Needles Seeker Crossing Support Catheter Presto Inflation Device BD Trek Bone Marrow Biopsy System BD Trek Power Driver BD Trek Bone Lesion Biopsy System BD Trek Sterile Sleeve LifeStream Balloon Expandable Vascular Covered Stent Vaccess PTA Dilatation Catheter Bard Burbank Carotid Bypass Shunt Bard Carotid Bypass Shunt Bard Javid Carotid Bypass Shunt Bard Brener Carotid Bypass Shunt ePTFE Cardiovascular Patch Spacer Links SourceLink Connectors SourceLink Brachytherapy Seeding EnCor Encompass VisiLoc MRI Introducer Set EnCor Probe Introducer EnCor VisiLoc MRI Introducer Set Covera Vascular Covered Stent Vascutrak PTA Dilatation Catheter HemoStar Long Term Hemodialysis Catheter GlidePath Long Term Hemodialysis Catheter HemoStar XK Long Term Hemodialysis Catheter UltraClip II US Tissue Marker Marker (Ribbon) UltraClip Dual Trigger Tissue GlidePath 13F Long Term Hemodialysis Catheter GlidePath 10F Long Term Dialysis Catheter LifeStream Balloon Expandable Vascular Covered Stent SenoMark UltraCor MRI Biopsy Site Markers SenoMark Biopsy Site Markers PT Stepper Surepoint PT Stepper Dynaflo Bypass Grafts UltraCor Twirl Breast Tissue Marker Magnum Core Biopsy Needles LifeStent XL Biliary Stent System LifeStent Biliary Stent System Illinois Bone Marrow Aspiration Needle Illinois Bone Marrow Aspiration Tray T-Handle Illinois Bone Marrow Aspiration Tray Safe-T PLUS Tray T-Handle Illinois Bone Marrow Aspiration Needle Bard Mission Disposable Core Biopsy Instrument Bard Mission Disposable Core Biopsy Instrument Kit EnCor Probe LifeStent Biliary Stent System Lifestent XL Biliary Stent System Rotarex Atherectomy System Rotarex S Straub Endovascular System UltraClip II MR Tissue Marker True Dilatation Balloon Valvuloplasty Catheter IMPRA Carboflo ePTFE Vascular Grafts Kelly-Wick AV Access Tunneler Venclose digiRF Generator Rotarex Atherectomy System Conquest PTA Dilatation Catheter BrachyStar Brachytherapy Needles brachytherapy seed implant needles BrachyStar Needles QuickLink Loader QuickLink Relay System SourceLink Loader UltraCor Twirl Breast Tissue Marker Usher Support Catheter Sidekick Support Catheter BrachySource Seed Implants ReadyLink Delivery System QuickLink Delivery System Gel Mark Ultra Biopsy Site Markers UltraCor Biopsy Site Markers Recon Support Catheter Aspirex Thrombectomy System Conquest 40 PTA Dilatation Catheter UltraScore Focused Force PTA Balloon Pristine Long Term Hemodialysis Catheter Prosthesis Vascular Graft of less than 6mm Valeo Biliary Stent Caterpillar Arterial Embolization Device Caterpillar Micro Arterial Embolization Device IMPRA Carboflo ePTFE Vascular Grafts Seedlinks SourceLink Connectors SourceLink Spacers Liverty TIPS Access Set Ultraverse 035 PTA Balloon Dilatation Catheter UltraCor Twirl Breast Tissue Marker BD EleVation Breast Biopsy System Venovo Venous Stent System EnCor EnCompass Breast Biopsy and Tissue Removal System Vacora Vacuum Assisted Biopsy Sys UltraClip Dual Trigger Breast Tissue Marker (Wing and Coil) Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Atlas PTA Balloon Dilatation Catheter EnCor Ultra Breast Biopsy System and Accessories EnCor Enspire Breast Biopsy System and Accessories Denali Vena Cava Filter, Jugular/Subclavian Delivery Kit Denali Vena Cava Filter, Femoral Delivery Kit Sidekick Support Catheter Usher Support Catheter PeritX 2L Drainage Starter Pack PeritX 2L Drainage Kit PeritX 2L Drainage Starter Tote PeritX Peritoneal Catheter System Crosser Generator Crosser CTO Recanalization Catheters 14S, S6 LifeStar Biliary Stent System E-LUMINEXX Biliary Stent System Venclose Foot Pedal Venclose digiRF Generator Venclose RF Ablation Catheters Venclose EVSRF System Venclose EVSRF Catheters UltraClip II Tissue Marker Wing and UltraClip II Tissue Marker Coil Stabilization System SurePoint Tracker Stepping and True BAV BAlloon Valvuloplasty Catheter Vida BAV Balloon Valvuloplasty Catheter EnCor Probe Introducer EnCor Ultrasound Stylet and Coaxial Marquee Disposable Core Biopsy Instrument Marquee Disposable Core Biopsy Instrument Kit GlidePath Retro Long Term Hemodialysis Catheter Gamma Finder, Sterile Sleeve Handheld Gamma Finder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-10-22
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2021-08-13
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2008-03-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-04-03
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2020-11-18
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-04-05
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	Unknown	Class 3	N/A	2009-02-24
FSH	Tray, Surgical, Needle	General, Plastic Surgery	Class 1	878.4800	2019-06-05
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2019-06-05
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2007-03-14
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2006-05-15
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-09-27
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2022-05-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-05-20
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2022-05-20
OMZ	Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter	Cardiovascular	Class 2	870.1250	2022-05-20
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2007-11-30
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	Class 2	870.3375	2007-12-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-09-15
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2021-09-15
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2007-12-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-05
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-11-11
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2008-11-11
NIO	Stent, Iliac	Unknown	Class 3	N/A	2009-02-20
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2019-06-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-09-19
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2010-08-27
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2011-01-10
DSW	Bag, Polymeric Mesh, Pacemaker	Cardiovascular	Class 1	870.3650	2007-03-14
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-10-31
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2007-12-05
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2010-09-02
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2018-08-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-08-06
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2007-03-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2011-05-26
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2015-02-02
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2022-03-30
PRL	Iliac Covered Stent, Arterial	Unknown	Class 3	N/A	2017-04-24
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2011-12-22
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2011-12-22
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2006-05-15
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2006-05-15
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2008-03-28
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2016-08-02
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	Unknown	Class 3	N/A	2018-07-30
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2011-12-22
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2022-05-16
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2008-11-11
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-11-11
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2021-06-07
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2020-07-17
NIO	Stent, Iliac	Unknown	Class 3	N/A	2016-08-03
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2010-09-02
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2007-12-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2007-12-10
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2005-12-27
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2016-06-14
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2007-03-14
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-02-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-06-05
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2017-10-26
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2010-09-01
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-02-06
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2020-10-30
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2020-10-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-11-11
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2015-06-18
DYF	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter	Cardiovascular	Class 2	870.3450	2007-12-05
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2026-01-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-09-19
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2025-02-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-02-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-01-14
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	1999-12-16
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2018-03-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-08-24
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2007-12-13
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2010-09-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-07-28
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2022-06-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-06-22
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-04-26
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-04-26
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2018-02-08
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	1995-11-06
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2021-04-05
DYF	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter	Cardiovascular	Class 2	870.3450	2006-05-15
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-02-06
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2020-02-05
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2007-12-05
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2008-03-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-05-31
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2014-09-24
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-03-25
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2019-11-13
QAN	Stent, Iliac Vein	Unknown	Class 3	N/A	2019-03-13
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2026-01-05
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2009-01-08
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2009-12-22
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2019-10-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-01-29
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2014-01-29
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2011-09-01
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	Class 2	870.3375	2016-09-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-12-09
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2025-01-09
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2011-10-06
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-07-19
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2007-08-24
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-08-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-29
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2008-11-11
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-11-11
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2011-05-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-05-09
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2014-09-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-09-02
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2025-07-28
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2021-07-01
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2011-05-26
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2011-05-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

C. R. Bard, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-04	Bard Peripheral Vascular Inc	N/A	Opti-Plast Balloon Dilatation Catheters
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0007-2014	Bard Peripheral Vascular Inc	3	Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 6.5 mm.
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
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.
Z-0038-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060303CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0039-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060401CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0040-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060403CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0041-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060601CD
Z-0042-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060603CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0043-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060801CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0044-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060803CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0044-2018	Bard Peripheral Vascular Inc	2	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2020394. Last updated year: 2026. Please use registration number 2020394 when referencing this establishment in official correspondence.