FDA.reportPublic FDA data

CLEARVIEW®

Primary DI
20885074257475
Brand
CLEARVIEW®
Company
MEDTRONIC, INC.
Model
31300
Device description
SHUNT ARTERIOTOMY 31300 3.00MM 15LA
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120612000
K993677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120612000MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNTMedtronic, Inc.2012-05-25DWF
K993677000MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNTMedtronic Vascular2000-04-17DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885074257475PrimaryGS10
00885074257471Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088507425747520885074257475
00885074257471008850742574718850742574710885074257471

GMDN Terms#

Term, Definition table
TermDefinition
Arteriovenous shuntA surgically-implanted device designed to provide a passage for blood to flow between an artery typically located in an arm, and a peripheral vein, central vein or right atrium, creating a graft fistula that provides blood access for external procedures, especially haemodialysis. It is a synthetic vascular graft/graft assembly with a thin wall and appropriate size (commonly 6 mm diameter) and configuration to facilitate vessel puncturing. It is typically used when it is not possible or convenient to create a direct ateriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
5
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00199150044177Concerto Versa™CVP-152026-10-18
00199150044184Concerto Versa™CVP-302026-10-18
00199150044191Concerto Versa™CVP-402026-10-18
00199150044207Concerto Versa™CVP-652026-10-18
00763000387020Symplicity G3™RDNG3A2023-11-30
00824846020073NABB10E56R162026-10-01
00643169845893Reveal LINQ™LNQ112020-01-19
00199150032402SenSight™B31030-S2026-09-28
00199150032426SenSight™B31030-D2026-09-28
00763000923709Power CordMCS1621PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00803622104091Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104107Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104114Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104121Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104138Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104145Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104152Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104169Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622105692Venous cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104176Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104183Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104190Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104206Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104213Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104220Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104237Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104244Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104251Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104268Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104275Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104282Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104299Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104305Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104312Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104329Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104336Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104343Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104350Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104367Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104374Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17