FDA.reportPublic FDA data

INFINITI

Primary DI
20705032052242
Brand
INFINITI
Company
CORDIS CORPORATION
Model
SRD6984
Catalog number
SRD6984
Device description
INF 5F .038 100CM RADIAL CURVE
Published
2024-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K970854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9708540005 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETERCordis Corp.1997-09-30DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032052242PackageGS15In Commercial Distribution
10705032052245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205224220705032052242
1070503205224510705032052245

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806136177
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
10705032000109RAIN Sheath® Tibial Pedal IntroducerTP506510NTP506510N2023-05-05
10705032078900RAIN Sheath Transradial506516S506516S2018-10-09
10705032078917RAIN Sheath Transradial506510S506510S2018-10-09
10705032079020RAIN Sheath Transradial506516H506516H2018-10-09
10705032079044RAIN Sheath Transradial506410S506410S2018-10-09
10705032082051RAIN Sheath Transradial506716P20G506716P20G2020-12-17
10705032082099RAIN Sheath Transradial506716N506716N2020-12-17
10705032082181RAIN Sheath Transradial506410N506410N2020-12-17
10705032100007RAIN Sheath® Tibial Pedal IntroducerTP506510STP506510S2023-05-05
20705032081211Brite Tip Radianz6872801356872801352022-03-30
20705032081228Brite Tip Radianz6872801106872801102022-03-30
10705032076845RAILWAYRW5ADTBRW5ADTB2018-05-31
10705032076852RAILWAYRW5VBTHRW5VBTH2018-05-31
10705032076913RAILWAYRW7VBTHRW7VBTH2018-05-31
10705032076920RAILWAYRW7VBTBRW7VBTB2018-05-31
10705032019057VISTA BRITE TIP598941P598941P2024-02-23
10705032019170VISTA BRITE TIP598949P598949P2024-02-23
10705032020138VISTA BRITE TIP67004800670048002024-02-23
10705032042956VISTA BRITE TIPSM7497SM74972024-02-23
10705032043069VISTA BRITE TIPSM7540SM75402024-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450836316Performa®Merit Medical Systems, Inc.DQO2026-10-07
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00884450787793Impress®Merit Medical Systems, Inc.DQO2026-09-18
00884450788868Impress®Merit Medical Systems, Inc.DQO2026-09-18
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
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07290017268347SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268354SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268378SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
00763000413767Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413774Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413781Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413798Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413804Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413811Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413828Rist™Micro Therapeutics, Inc.DQO2020-10-05
10841156105860GREBSETTELEFLEX INCORPORATEDDQO2020-01-27