FDA.reportPublic FDA data

INFINITI™ AMBI

Primary DI
10705032100106
Brand
INFINITI™ AMBI
Company
Cordis US Corp.
Model
555600T401
Catalog number
555600T401
Device description
6F INFINITI AMBI 100CM TG 4.0
Published
2024-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCatheter, intravascular, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232573000INFINITI™ Ambi Angiographic CatheterCordis US Corp2023-11-21DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032100103PackageGS15Not in Commercial Distribution
10705032100106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503210010320705032100103
1070503210010610705032100106

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Regulatory Flags#

DUNS number
118274128
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032057004AQUATRACK™ Hydrophilic Nitinol GuidewireC3515RSAC3515RSA2026-07-29
10705032057011AQUATRACK™ Hydrophilic Nitinol GuidewireC3515RSSC3515RSS2026-07-29
10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireC3515SSAC3515SSA2026-07-29
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireC3518RSAC3518RSA2026-07-29
10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireC3518RSSC3518RSS2026-07-29
10705032057059AQUATRACK™ Hydrophilic Nitinol GuidewireC3518SSAC3518SSA2026-07-29
10705032057066AQUATRACK™ Hydrophilic Nitinol GuidewireC3526RSAC3526RSA2026-07-29
10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireC3526SSAC3526SSA2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireC3526SSSC3526SSS2026-07-29
10705032100656VISTA BRITE TIP778-052-00M778-052-00M2024-09-09
10705032100663VISTA BRITE TIP778-082-00M778-082-00M2024-09-09
10705032100748VISTA BRITE TIP670-190-00M670-190-00M2024-09-09
10705032100830VISTA BRITE TIP670-040-00M670-040-00M2024-09-09
10705032100892VISTA BRITE TIP778-034-00M778-034-00M2024-09-09
10705032100922VISTA BRITE TIP670-008-00M670-008-00M2024-09-09
10705032100953VISTA BRITE TIP778-270-00M778-270-00M2024-09-09
10862028000434MYNX CONTROLMX6760MX67602018-10-22
10862028000427MYNX CONTROLMX5060MX50602018-10-22
20705032036440Cordis PRECISE PRO Rx Nitinol Stent SystemPC0720RXCPC0720RXC2014-09-17
10705032009768AVANTI504405X504405X2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403522324Swan-GanzBecton, Dickinson And CompanyDQO2026-07-31
00885403522393Swan-GanzBecton, Dickinson And CompanyDQO2026-07-27
00885403522300Swan-GanzBecton, Dickinson And CompanyDQO2026-07-24
10841156111311LANGSTONTELEFLEX INCORPORATEDDQO2026-07-23
10841156112035LANGSTONTELEFLEX INCORPORATEDDQO2026-06-26
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
07290017268316SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268323SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268330SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268361SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268385SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268392SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268408SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268804DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268811DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268828DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268866DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268873DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268880DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268309SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268835DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268842DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268859DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17