FDA.reportPublic FDA data

Tigereye ST

Primary DI
00851354004554
Brand
Tigereye ST
Company
AVINGER, INC.
Model
O350
Catalog number
O350
Device description
The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.
Published
2023-07-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NQQSystem, Imaging, Optical Coherence Tomography (Oct)
PDUCatheter For Crossing Total Occlusions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2
PDUCatheter For Crossing Total OcclusionsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230594000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230594000Tigereye ST CTO-Crossing CatheterAvinger, Inc.2023-04-25PDU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851354004554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851354004554008513540045548513540045540851354004554

GMDN Terms#

Term, Definition table
TermDefinition
Blunt-microdissection atherectomy catheterA manually-powered instrument intended to be used to create a pathway through an occluded blood vessel to facilitate the intraluminal placement of a conventional guidewire beyond a stenotic lesion [especially a chronic total occlusion (CTO) of a coronary artery], prior to further percutaneous intervention to remove the lesion. It typically consists of a long, thin, flexible segment, introduced into the vasculature, that is equipped to mechanically disrupt the lesion (e.g., by blunt microdissection) through manipulation of hand controls at the proximal end. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
8002082988cs@avinger.com

Regulatory Flags#

DUNS number
003152968
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851354004417Pantheris SVA140-SVA140-SV2019-08-02
00851354004189Ocelot IIIO200O2002019-03-21
00851354004233Ocelot IVO250O2502019-03-21
00851354004271CO2C100C1002019-03-21
00851354004370PantherisA400A4002019-03-21
00851354004387Pantheris A400XA400X2019-03-21
00851354004493TigereyeO300O3002023-03-14
00851354004509Lightbox L3L300L3002024-01-29
00851354004578Pantheris LVLVA110-LV2024-01-29
00851354004264Sterile DrapeSD100SD1002019-03-21
00851354004004WildcatW400W4002019-03-21
00851354004028WildcatE400E4002019-03-21
00851354004042Kittykat IIW550`W5502019-03-21
00851354004059Kittykat IIE550E5502019-03-21
00851354004073JuiceboxJ100J1002019-03-21
00851354004127Lightbox Umbilical U100U1002019-03-21
00851354004141Ocelot PIXLP135P1352019-03-21
00851354004301Lightbox Umbilical U250U2502019-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00812763011007OPUSWAVETerumo Cardiovascular Systems CorporationNQQ2026-05-13
06975417183858PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183865PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
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
06971141530494Cornaris Intravascular Imaging SystemShenzhen Vivolight Medical Device & Technology Co., Ltd.NQQ2025-09-28
06971141530500Cornaris Intravascular Imaging SystemShenzhen Vivolight Medical Device & Technology Co., Ltd.NQQ2025-09-28
03775000102715deepLiveDAMAE MEDICALNQQ2025-09-24
05415067053879ILUMIEN™ OPTIS™ to OPTIS™LIGHTLAB IMAGING, INC.NQQ2025-07-31
00845225003425Pioneer Plus CatheterPhilips Image Guided Therapy CorporationPDU2024-08-12
00850041730158LimFlow ARCInari Medical, Inc.PDU2024-04-19
05415067047694Ultreon™LIGHTLAB IMAGING, INC.NQQ2024-03-29
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
00860008045508Starlight Imaging CatheterSpectrawave, Inc.NQQ2024-02-23
00860008045515HyperVue Imaging SystemSpectrawave, Inc.NQQ2024-02-23
00851354004509Lightbox L3AVINGER, INC.NQQ2024-01-29
05415067048882AptiVue™LIGHTLAB IMAGING, INC.NQQ2023-09-29
06932503570022Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570039Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11