FDA.reportPublic FDA data

SUPER TORQUE

Primary DI
10705032050371
Brand
SUPER TORQUE
Company
CORDIS CORPORATION
Model
SRD6616
Catalog number
SRD6616
Device description
5F ST 0.035 INCHES 80CM 6SH
Published
2016-08-01
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
K915836000
K992347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915836000CORDIS 5.0 FRENCH SUPER TORQUE CATHETERSCordis Corp.1992-02-11DQO
K992347000CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDSCordis Corp.1999-10-08DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032050378PackageGS15In Commercial Distribution
10705032050371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205037820705032050378
1070503205037110705032050371

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
Lot or batch
true
Expiration date on label
true

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
10801902208580ARROWTELEFLEX INCORPORATEDDQO2024-02-05
10801902208542ARROWTELEFLEX INCORPORATEDDQO2023-06-12
10801902208559ARROWTELEFLEX INCORPORATEDDQO2023-06-06
10801902192254ARROWTELEFLEX INCORPORATEDDQO2022-11-29
10801902192285ARROWTELEFLEX INCORPORATEDDQO2022-11-08
00763000541194RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541200RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541217RistTMMicro Therapeutics, Inc.DQO2022-05-01
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