FDA.reportPublic FDA data

FilterWire EZ™

Primary DI
08714729470854
Brand
FilterWire EZ™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H749201001900
Device description
Embolic Protection System
Published
2016-09-24
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
NFATemporary Coronary Saphenous Vein Bypass Graft for Embolic Protection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic ProtectionCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729470854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729470854087147294708548714729470854

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447020677RFP-100A™ RF Puncture GeneratorM004RFP100A0M004RFP100A02026-06-08
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729470861FilterWire EZ™BOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
08714729479109EZ Bent TipBOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
08714729808800FilterWire EZ™BOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
08714729808817FilterWire EZ™BOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
10721902644020GuardWire®MEDTRONIC, INC.NFA2016-09-01
10721902644037GuardWire®MEDTRONIC, INC.NFA2016-05-15
10721902644174GuardWire®MEDTRONIC, INC.NFA2016-05-15
10721902644167GuardWire®MEDTRONIC, INC.NFA2016-05-15
00821684040331SpiderFXCovidien LPNFA2015-10-16
00821684040348SpiderFXCovidien LPNFA2015-10-16
00821684040355SpiderFXCovidien LPNFA2015-10-16
00821684040362SpiderFXCovidien LPNFA2015-10-16
00821684040379SpiderFXCovidien LPNFA2015-10-16
00821684040485SpiderFXCovidien LPNFA2015-10-16
00821684040492SpiderFXCovidien LPNFA2015-10-16
00821684040508SpiderFXCovidien LPNFA2015-10-16
00821684040515SpiderFXCovidien LPNFA2015-10-16
00821684040522SpiderFXCovidien LPNFA2015-10-16