FDA.reportPublic FDA data

TruePath™

Primary DI
08714729820284
Brand
TruePath™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74939208181650
Device description
CTO Device
Published
2016-09-24
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
PDUCatheter for crossing total occlusions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDUCatheter For Crossing Total OcclusionsCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729820284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729820284087147298202848714729820284

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, poweredA sterile, battery–powered wire with a rotational cutting tip intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to create a pathway through a chronic vascular obstruction [e.g., a chronic total occlusion (CTO)], and to function as a guide for the introduction of another device (e.g., manual guidewire, catheter). It consists of a long, thin, shapeable/steerable wire and a detachable battery-powered motor/control unit; it is typically used under fluoroscopic guidance. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540299000426PowerWire 14 Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2025-12-04
07540299000433PowerWire 14 Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2025-12-04
07540299000471PowerWire 14 Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2025-12-04
07540299000488PowerWire 14 Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2025-12-04
00860009199705Santreva-ATK Endovascular Revascularization CatheterAngiosafe, Inc.PDU2025-12-03
00845225003425Pioneer Plus CatheterPhilips Image Guided Therapy CorporationPDU2024-08-12
00850041730158LimFlow ARCInari Medical, Inc.PDU2024-04-19
07540299000372PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
07540299000389PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
07540299000396PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
07540299000402PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
07540299000419PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
00851354004554Tigereye STAVINGER, INC.PDU2023-07-24
00850041730011LimFlow ARCInari Medical, Inc.PDU2023-06-26
07540299000228PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000235PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000242PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000259PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000266PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000273PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
04260279096456BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
04260279096463BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
04260279096470BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
04260279096487BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
00851354004493TigereyeAVINGER, INC.PDU2023-03-14
07290017837109GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
07290017837116GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
07290017837222GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
07290017837239GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
00801741202438Recanalization SystemBard Peripheral Vascular, Inc.PDU2022-03-30