FDA.reportPublic FDA data

VENOUS WALLSTENT™

Primary DI
08714729979425
Brand
VENOUS WALLSTENT™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74912044106870
Catalog number
H74912044106870
Device description
Self-Expanding Stent
Published
2020-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QANStent, iliac vein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QANStent, Iliac VeinUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980033050

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980033050WALLSTENT ENDOPROSTHESISBoston Scientific Corporation2001-11-16QKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729979425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729979425087147299794258714729979425

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal tracheal/bronchial/vascular stentA sterile, non-bioabsorbable, tubular device intended to be implanted to indefinitely maintain patency/improve luminal diameter of a blood vessel (peripheral artery and/or vein) and, alternatively, the tracheobronchial tree; it may in addition be intended to be used in the biliary tract. It is not intended for implantation in a coronary or cerebral artery and not intended for shunting. It is a tubular bare-metal mesh implanted with a balloon catheter or delivery device (balloon and/or self-expanding). It is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length75Centimeter
Stent Diameter10Millimeter
Stent Length68Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810010693266Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693280Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693327Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693341Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693440Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693457Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693464Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693471Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694782Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694829Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694836Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694843Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694850Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694898Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
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