FDA.reportPublic FDA data

ARROW

Primary DI
10801902128703
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN001390
Catalog number
CS-15552-VF
Device description
Arrow-Clark(TM) VectorFlow(TM) Retrograde Hemodialysis Catheter
Published
2016-09-16
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
MSDCatheter, hemodialysis, implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSDCatheter, Hemodialysis, ImplantedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141051000VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HUArrow International, Inc.2014-07-07MSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30801902128707PackageGS11In Commercial Distribution
40801902128704PackageGS11In Commercial Distribution
10801902128703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3080190212870730801902128707
4080190212870440801902128704
1080190212870310801902128703

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableAn implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704927910PILLINGIPN0079065068002026-07-08
10801902226171ARROWPR-45552-BASPR-45552-BAS2026-07-06
10841156112035LANGSTONIPN93901955402026-06-26
10801902218732ARROWIPN928981CS-15853-E2026-06-24
10801902221725ARROWIPN930533EC-055002026-06-24
14026704664983HUDSON RCIIPN039676158002026-06-24
14026704664990HUDSON RCIIPN039677158022026-06-24
14026704665003HUDSON RCIIPN039678158042026-06-24
14026704665027HUDSON RCIIPN039680158082026-06-24
14026704665034HUDSON RCIIPN039681158102026-06-24
14026704665164HUDSON RCIIPN03969412712026-06-24
14026704665171HUDSON RCIIPN03969512722026-06-24
14026704665195HUDSON RCIIPN03969712742026-06-24
14026704665201HUDSON RCIIPN03969812752026-06-24
14026704924254PLEUR-EVACIPN929357PE104-082026-06-24
15060112315029LMA AIRWAY MANAGEMENTIPN0487781280302026-06-24
15060112315036LMA AIRWAY MANAGEMENTIPN0487801280402026-06-24
15060112315043LMA AIRWAY MANAGEMENTIPN0487821280502026-06-24
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450468913DuraMax®Merit Medical Systems, Inc.MSD2026-07-08
00884450820759CentrosFLO®Merit Medical Systems, Inc.MSD2026-06-25
00884450467572DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450469033BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450469132BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450794760DuraMax®Merit Medical Systems, Inc.MSD2026-06-02
10801902096606ARROWTELEFLEX INCORPORATEDMSD2018-06-26
10801902096620ARROWTELEFLEX INCORPORATEDMSD2018-06-26
10801902096668ARROWTELEFLEX INCORPORATEDMSD2018-06-26
10801741074490ClampsBard Access Systems, Inc.MSD2016-09-16
10801902126693ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126709ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126716ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126723ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126730ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126747ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126754ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126761ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126778ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126785ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126792ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126808ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127157ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127164ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127171ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127188ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127195ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127201ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127218ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127225ARROWTELEFLEX INCORPORATEDMSD2016-09-16