AVINGER, INC.

Address:400 Chesapeake Drive,Redwood City,CA,94063,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Optical Coherence Tomography (Oct) (NQQ) (4) Catheter, Peripheral, Atherectomy (MCW) (3) Regulator, Pressure, Gas Cylinder (CAN) (1)

Premarket Exempt

Yes No

Clear

CO2 - 00851354004271 Catalog Number : C100

Device Description : The CO2 Regulator System is intended to supply low pressure CO2, where small vol The CO2 Regulator System is intended to supply low pressure CO2, where small volumes of CO2 are needed, during medical procedures. The device is not intended to be marketed for any specific treatment or medical purpose.The CO2 Cartridge is a component of the Avinger CO2 Regulator System which also includes a CO2 regulator (regulator), male luer lock connector and a female-female luer lock connector (removable). The Avinger CO2 Regulator System allows for the CO2 cartridge to be replaced once the gas from the engaged CO2 cartridge has been spent. Replacement CO2 Cartridges are shipped in packs of five (5).

Device Class : 1

Duns Number: 003152968

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : Yes

Device Count : 1

Lightbox Umbilical - 00851354004301 Catalog Number : U250

Device Description : Lightbox Umbilical is intended for use in peripheral vascular procedures in conj Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product.

Device Class : 2

Duns Number: 003152968

Premarket Exempt : Yes

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

Pantheris - 00851354004370 Catalog Number : A400

Device Description : The Pantheris System is intended to remove plaque (atherectomy) from partially o The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

Device Class : 2

Duns Number: 003152968

Premarket Exempt : No

Product Code : NQQ, MCW

Prescription Use : Yes

Device Count : 1

Pantheris - 00851354004387 Catalog Number : A400X

Device Class : 2

Duns Number: 003152968

Premarket Exempt : No

Product Code : NQQ, MCW

Prescription Use : Yes

Device Count : 1

Pantheris SV - 00851354004417 Catalog Number : A140-SV

Device Description : The Pantheris SV System is intended to remove plaque (atherectomy) from partiall The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

Device Class : 2

Duns Number: 003152968

Premarket Exempt : No

Product Code : NQQ, MCW

Prescription Use : Yes

Device Count : 1

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