FDA.reportPublic FDA data

CARTO VIZIGO

Primary DI
10846835026269
Brand
CARTO VIZIGO
Company
Biosense Webster Inc
Model
D138505
Catalog number
D138505
Device description
CARTO VIZIGO Bi-Directional Guiding Sheath
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBIntroducer, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170997000CARTO VIZIGO 8.5F Bi-Directional Guiding SheathBiosense Webster, Inc.2017-07-25DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846835026269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084683502626910846835026269

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Keep out of direct sunlight
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)729-9010RA-BWIUS-Complaints@its.jnj.com

Regulatory Flags#

DUNS number
020163218
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10846835026726Dual Energy Thermocool Smarttouch SF CatheterD134711D1347112026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterD134712D1347122026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterD134713D1347132026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterD134811D1348112026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterD134812D1348122026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterD134813D1348132026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterD134814D1348142026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterD134815D1348152026-07-09
10846835010121Sterile Interface CableD133701D1337012024-12-11
10846835016796TX eco EXT CableD135703D1357032023-10-04
10846835000184N/AC10MR10MSTKSC10MR10MSTKS2017-09-13
10846835000191N/AC5MHDTCMHSC5MHDTCMHS2017-09-13
10846835000207N/AC5MHNAVMHSC5MHNAVMHS2017-09-13
10846835000214N/AC5MHREFMHSC5MHREFMHS2017-09-13
10846835003666N/AC6MR10EPTRSC6MR10EPTRS2017-09-13
10846835003789Carto 3CB3410CTCB3410CT2016-09-16
10846835003796Carto 3CB3412CTCB3412CT2016-09-16
10846835003802Carto 3CB3434CTCB3434CT2016-09-16
10846835003826Carto 3CG2025CTCG2025CT2016-09-16
10846835003857Carto 3CR3425CTCR3425CT2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902226416ARROWTELEFLEX INCORPORATEDDYB2026-08-03
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DYB2026-07-31
06974949033792CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
06974949033808CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
10801902193114ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193121ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193190ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193206ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196184ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196498ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196511ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196528ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902200768ARROWTELEFLEX INCORPORATEDDYB2026-07-30
06974949033785CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-29
10801902196412ARROWTELEFLEX INCORPORATEDDYB2026-07-29
20801902193470ARROWTELEFLEX INCORPORATEDDYB2026-07-29
10801902189872ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902196436ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902198850ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902226409ARROWTELEFLEX INCORPORATEDDYB2026-07-27
10801902226485ARROWTELEFLEX INCORPORATEDDYB2026-07-22
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDYB2024-08-19