FDA.reportPublic FDA data

ANGIOGUARD

Primary DI
20705032054789
Brand
ANGIOGUARD
Company
CORDIS CORPORATION
Model
501814REC
Catalog number
501814REC
Device description
5MM BASKET, EXTRA SUPPORT,
Published
2021-01-26
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
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
K101651000
K220654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101651000ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRECordis Corp.2010-07-09NTE
K220654000ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation2022-04-06NTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032054789PackageGS11In Commercial Distribution
10705032054782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205478920705032054789
1070503205478210705032054782

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.

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
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
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