FDA.reportPublic FDA data

ANGIOGUARD

Primary DI
10705032053501
Brand
ANGIOGUARD
Company
CORDIS CORPORATION
Model
401814RMC
Catalog number
401814RMC
Device description
4mm basket, Medium Support
Published
2022-04-11
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
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
20705032053508PackageGS11In Commercial Distribution
10705032053501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205350820705032053508
1070503205350110705032053501

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
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
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
10705032043144VISTA BRITE TIPSM7548SM75482024-02-23
10705032043151VISTA BRITE TIPSM7549SM75492024-02-23
10705032043434VISTA BRITE TIPSM7596SM75962024-02-23
10705032043779VISTA BRITE TIPSM7652SM76522024-02-23
10705032047050VISTA BRITE TIPSRA0002IGSRA0002IG2024-02-23
10705032047135VISTA BRITE TIPSRA0016IGSRA0016IG2024-02-23
10705032056625ATW Marker Wire Steerable Guidewires595MEJ014595MEJ0142021-01-26
20705032064863VISTA BRITE TIPSM7732SM77322024-02-23
20705032064870VISTA BRITE TIPSM7733SM77332024-02-23
20705032064887VISTA BRITE TIPSM7731SM77312024-02-23
20705032065143VISTA BRITE TIPSM7737SM77372024-02-23
10705032017169VISTA BRITE TIP588823E588823E2016-08-01
10705032017268VISTA BRITE TIP588830E588830E2016-08-01
10705032017299VISTA BRITE TIP588831E588831E2016-08-01
10705032017343VISTA BRITE TIP588834E588834E2016-08-01

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
10705032053556ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032054805ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032055819ANGIOGUARDCordis US Corp.NTE2022-04-11
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