FDA.reportPublic FDA data

COVERA

Primary DI
00801741106859
Brand
COVERA
Company
Angiomed GmbH & Co. Medizintechnik KG
Model
AVSL10080
Catalog number
AVSL10080
Device description
COVERA™ Vascular Covered Stent 10 mm x 80 mm (120 cm delivery catheter) (straight)
Published
2018-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PFVSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P170042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170042000Covera™ Vascular Covered StentC.R. Bard, Inc.2018-07-30PFV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741106859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741106859008017411068598017411068590801741106859

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral venous endovascular stent-graftA sterile non-bioabsorbable tubular device designed to be implanted in a peripheral vein to maintain vessel lumen patency, typically to treat stenosis in the outflow of an arteriovenous fistula (AVF) or graft used for haemodialysis. It is a mesh structure made of metal [e.g., nickel-titanium alloy (Nitinol)] that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft), and contains an inner carbon coating to help prevent platelet adhesion. It is typically expanded in situ (e.g., self-expands or balloon-expandable) and disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
320047483
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741103131Venovo®VENUM10040VENUM100402019-03-18
00801741103148Venovo®VENUM10060VENUM100602019-03-18
00801741103155Venovo®VENUM10080VENUM100802019-03-18
00801741103162Venovo®VENUM10100VENUM101002019-03-18
00801741103179Venovo®VENUM10120VENUM101202019-03-18
00801741103186Venovo®VENUM10140VENUM101402019-03-18
00801741103193Venovo®VENUM10160VENUM101602019-03-18
00801741103209Venovo®VENUL10040VENUL100402019-03-18
00801741103216Venovo®VENUL10060VENUL100602019-03-18
00801741103223Venovo®VENUL10080VENUL100802019-03-18
00801741103230Venovo®VENUL10100VENUL101002019-03-18
00801741103247Venovo®VENUL10120VENUL101202019-03-18
00801741103254Venovo®VENUL10140VENUL101402019-03-18
00801741103261Venovo®VENUL10160VENUL101602019-03-18
00801741103278Venovo®VENUM12040VENUM120402019-03-18
00801741103285Venovo®VENUM12060VENUM120602019-03-18
00801741103292Venovo®VENUM12080VENUM120802019-03-18
00801741103308Venovo®VENUM12100VENUM121002019-03-18
00801741103315Venovo®VENUM12120VENUM121202019-03-18
00801741103322Venovo®VENUM12140VENUM121402019-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450845400WRAPSODY®Merit Medical Systems, Inc.PFV2026-05-05
00884450845561WRAPSODY®Merit Medical Systems, Inc.PFV2026-04-21
00884450845387WRAPSODY®Merit Medical Systems, Inc.PFV2026-02-14
00884450845851WRAPSODY®Merit Medical Systems, Inc.PFV2025-12-16
00884450845813WRAPSODY®Merit Medical Systems, Inc.PFV2025-10-07
00884450845608WRAPSODY®Merit Medical Systems, Inc.PFV2025-08-08
00884450845806WRAPSODY®Merit Medical Systems, Inc.PFV2025-07-01
00884450845844WRAPSODY®Merit Medical Systems, Inc.PFV2025-06-18
00884450845615WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-24
00884450845905WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-24
00884450845417WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-15
00884450845790WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-15
00884450845394WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-14
00884450845653WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-13
00884450845691WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-13
00884450845714WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-13
00884450845639WRAPSODY®Merit Medical Systems, Inc.PFV2025-04-21
00884450845660WRAPSODY®Merit Medical Systems, Inc.PFV2025-04-18
00884450845462WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-22
00884450845622WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-22
00884450845684WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-15
00884450845950WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-08
00884450845967WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-08
00884450845646WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-04
00884450845738WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-21
00884450845516WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-12
00884450845677WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-12
00884450845776WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-06
00884450845899WRAPSODY®Merit Medical Systems, Inc.PFV2025-01-30
00884450845752WRAPSODY®Merit Medical Systems, Inc.PFV2025-01-29