FDA.reportPublic FDA data

Accunet

Primary DI
08717648085178
Brand
Accunet
Company
ABBOTT VASCULAR INC.
Model
1011649-65
Catalog number
1011649-65
Device description
RX ACCUNET Embolic Protection System 6.5/190 Rapid-Exchange
Published
2016-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717648085178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717648085178087176480851788717648085178

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, dark, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-9902AV.CUSTOMERCARE@AV.ABBOTT.COM

Regulatory Flags#

DUNS number
964569052
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
08717648353765Esprit™Esprit™1212375-282025-07-12
08717648353666Esprit™Esprit™1212350-182025-07-10
08717648353680Esprit™Esprit™1212350-282025-07-10
08717648353703Esprit™Esprit™1212350-382025-07-10
08717648353741Esprit™Esprit™ 1212375-182025-07-10
08717648353789Esprit™Esprit™1212375-382025-07-10
08717648353826Esprit™Esprit™1212250-182025-07-10
08717648353840Esprit™Esprit™1212250-282025-07-10
08717648353864Esprit™Esprit™1212250-382025-07-10
08717648353987Esprit™Esprit™1212300-182025-07-10
08717648354007Esprit™Esprit™1212300-282025-07-10
08717648354021Esprit™Esprit™1212300-382025-07-10
08717648356704XACT™83024-0183024-012025-04-17
08717648356742XACT™ 83022-0183022-012025-04-17
08717648356766XACT™83020-0183020-012025-04-17
08717648356803XACT™83026-0183026-012025-04-17
08717648356810HI-TORQUE COMMAND™ 106000110600012024-11-21
08717648356827HI-TORQUE COMMAND™ 1060001A1060001A2024-11-21
08717648356834HI-TORQUE COMMAND™106000210600022024-11-21
08717648356841HI-TORQUE COMMAND™ 1060002A1060002A2024-11-21

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
00811311021062ENROUTE Transcarotid Neuroprotection SystemSILK ROAD MEDICAL, INC.NTE2023-04-24
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
20705032056851ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032056899ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032056936ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032056943ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10850000491882WirionCardiovascular Systems, Inc.NTE2021-03-05
20705032054789ANGIOGUARDCORDIS CORPORATIONNTE2021-01-26
20705032056721ANGIOGUARDCORDIS CORPORATIONNTE2021-01-26
08033477090719MO.MA ULTRAMEDTRONIC, INC.NTE2020-10-30
08033477071909MO.MA ULTRAMEDTRONIC, INC.NTE2018-05-12
00733132618255GORE Embolic FilterW. L. Gore & Associates, Inc.NTE2017-02-13
H373GEFA01530039GORE Embolic FilterW. L. Gore & Associates, Inc.NTE2017-02-13
00733132618279GORE Embolic FilterW. L. Gore & Associates, Inc.NTE2017-02-13
00733132618286GORE Embolic FilterW. L. Gore & Associates, Inc.NTE2017-02-13
07290015512015Wirion System kit Finished GoodGARDIA MEDICAL LTDNTE2017-02-12
07290015512022Wirion Delivery CatheterGARDIA MEDICAL LTDNTE2017-02-12
72900155120301Wirion Retrieval CatheterGARDIA MEDICAL LTDNTE2017-02-12
00811311020829ENROUTE Transcarotid Neuroprotection SystemSILK ROAD MEDICAL, INC.NTE2017-01-25
72900155120103Wirion System kit Finished GoodGARDIA MEDICAL LTDNTE2016-08-11
72900155120202Wirion Delivery CatheterGARDIA MEDICAL LTDNTE2016-08-11
00821684068304SpiderFX™Covidien LPNTE2016-07-23