FDA.reportPublic FDA data

CARTO VIZIGO

Primary DI
10846835026252
Brand
CARTO VIZIGO
Company
Biosense Webster Inc
Model
D138504
Catalog number
D138504
Device description
CARTO VIZIGO Bi-Directional Guiding Sheath
Published
2026-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
10846835026252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084683502625210846835026252

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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. 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 Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
020163218
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10846835026269CARTO VIZIGOD138505D1385052026-05-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00850291007260Intri24 Introducer SheathInari Medical, Inc.DYB2023-03-20
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
04251244500641DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500719DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500801DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500818DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500832DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500849DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500856DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501099DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501075DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501082DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500795DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2020-11-04
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012377R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012384R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
04251244500108DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500115DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500122DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500139DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500146DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30