FDA.reportPublic FDA data

CORDIS SUPER TORQUE

Primary DI
10705032009157
Brand
CORDIS SUPER TORQUE
Company
Cordis US Corp.
Model
455636
Catalog number
455636
Device description
CATH ST ENDO 6F MP A2 80CM 2SH
Published
2017-09-18
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
K914007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914007000CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATHCordis Corp.1991-10-18DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032009154PackageGS15In Commercial Distribution
10705032009157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503200915420705032009154
1070503200915710705032009157

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118274128
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10705032009775AVANTI504406X504406X2016-08-01
10705032009799AVANTI504408X504408X2016-08-01
10705032009881AVANTI504509X504509X2016-08-01
10705032009898AVANTI504604A504604A2016-08-01
10705032009904AVANTI504604P504604P2016-08-01
10705032009911AVANTI504604S504604S2016-08-01
10705032009935AVANTI504604X504604X2016-08-01
10705032009942AVANTI504605A504605A2016-08-01
10705032009959AVANTI504605P504605P2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
08714729152989Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729188865Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200291Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213161Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213178Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213185Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213192Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213208Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213369Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213666Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213741Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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08714729213918Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214007Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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08714729214441Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214472Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214502Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214632Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214656Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214663Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214816Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214830Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24