VENOUS WALLSTENT™

Primary DI
08714729979531
Brand
VENOUS WALLSTENT™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74912044146070
Catalog number
H74912044146070
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
08714729979531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729979531087147299795318714729979531

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 Diameter14Millimeter
Stent Length60Millimeter

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
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

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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