FDA.reportPublic FDA data

VICI RDS™ Venous Stent System

Primary DI
00852725008232
Brand
VICI RDS™ Venous Stent System
Company
Veniti Inc
Model
H74914120790
Catalog number
H74914120790
Published
2020-09-15
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
P180013004

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180013004VICI VENOUS STENT SystemBoston Scientific Corporation2019-05-02QAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852725008232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852725008232008527250082328527250082320852725008232

GMDN Terms#

Term, Definition table
TermDefinition
Iliofemoral vein stentA sterile non-bioabsorbable tubular device intended to be implanted in an iliac and/or femoral vein to maintain patency in patients with constrained venous outflow. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. The device is typically made of nickel-titanium alloy (Nitinol) and has radiopaque marker(s) for visualization; it is available in a variety of diameters and lengths. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length79Centimeter
Stent Diameter14Millimeter
Stent Length120Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079757164
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852725008188VICI RDS™ Venous Stent SystemH74912060710H749120607102020-09-15
00852725008195VICI RDS™ Venous Stent SystemH74912090750H749120907502020-09-15
00852725008201VICI RDS™ Venous Stent SystemH74912120790H749121207902020-09-15
00852725008218VICI RDS™ Venous Stent SystemH74914060710H749140607102020-09-15
00852725008225VICI RDS™ Venous Stent SystemH74914090750H749140907502020-09-15
00852725008249VICI RDS™ Venous Stent SystemH74916060710H749160607102020-09-15
00852725008256VICI RDS™ Venous Stent SystemH74916090750H749160907502020-09-15
00852725008263VICI RDS™ Venous Stent SystemH74916120790H749161207902020-09-15
00852725008096VICI VENOUS STENT ® SYSTEMH74912060100H749120601002019-05-09
00852725008102VICI VENOUS STENT ® SYSTEMH74912090100H749120901002019-05-09
00852725008119VICI VENOUS STENT ® SYSTEMH74912120100H749121201002019-05-09
00852725008126VICI VENOUS STENT ® SYSTEMH74914060100H749140601002019-05-09
00852725008133VICI VENOUS STENT ® SYSTEMH74914090100H749140901002019-05-09
00852725008140VICI VENOUS STENT ® SYSTEMH74914120100H749141201002019-05-09
00852725008157VICI VENOUS STENT ® SYSTEMH74916060100H749160601002019-05-09
00852725008164VICI VENOUS STENT ® SYSTEMH74916090100H749160901002019-05-09
00852725008171VICI VENOUS STENT ® SYSTEMH74916120100H749161201002019-05-09

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
10827002574295Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574301Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574318Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574325Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574332Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574349Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574356Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574363Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574370Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574387Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574394Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574400Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574417Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574424Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574431Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574448Zilver VenaCOOK IRELAND LTDQAN2020-11-04