FDA.reportPublic FDA data

ANGIOGUARD

Primary DI
10705032055819
Brand
ANGIOGUARD
Company
Cordis US Corp.
Model
503014MC
Catalog number
503014MC
Device description
5mm basket/ Medium Support
Published
2022-04-11
Public version status
Update
Distribution status
Not 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
NTETemporary Carotid Catheter For Embolic Capture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTETemporary Carotid Catheter For Embolic CaptureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220654000ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation2022-04-06NTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032055816PackageGS11Not in Commercial Distribution
10705032055819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205581620705032055816
1070503205581910705032055819

GMDN Terms#

Term, Definition table
TermDefinition
Embolic protection filtering guidewireA steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. 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
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
00842429117224Nanoparasol, Peel AwayMicrovention, Inc.NTE2025-08-01
00842429117231Nanoparasol, Peel AwayMicrovention, Inc.NTE2025-08-01
00851616007149Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007156Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007293PaladinContego Medical, Inc.NTE2023-09-05
00851616007385Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007453Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007460Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007477PaladinContego Medical, Inc.NTE2023-09-05
00851616007538Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007002PaladinContego Medical, Inc.NTE2023-09-05
00851616007309PaladinContego Medical, Inc.NTE2023-09-05
00811311021062ENROUTE Transcarotid Neuroprotection SystemBOSTON SCIENTIFIC CORPORATIONNTE2023-04-24
10705032053501ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032053556ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032054805ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056748ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056793ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032056830ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056854ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056892ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032056939ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056946ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032053508ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032053553ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032054802ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032055816ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032056745ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032056790ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032056837ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11