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Pantheris LV

FDA UDI

Class II (US FDA UDI)

by Avinger, Inc.

Identity

Trade Name
Pantheris LV FDA UDI
Generic Name
Mechanical atherectomy system catheter, peripheral FDA UDI
Device Name
The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F sheaths and 0.014” guidewires. It consists of a lubricious coated torque shaft with a proximal handle assembly and an atraumatic distal assembly. The distal assembly of the catheter consists of an imaging assembly, a rotating cutter, an apposition jog, and a flexible, tiltable nosecone with a radiopaque fuel gauge. The distal end of the catheter includes an approximately 13 cm length guidewire lumen, accommodating standard 0.014” guidewires. The nosecone component of the catheter is 6 cm long. The catheter is sterilized by electron beam and is intended for single use only. FDA UDI
Model / Reference
LV FDA UDI
Description
The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F sheaths and 0.014” guidewires. It consists of a lubricious coated torque shaft with a proximal handle assembly and an atraumatic distal assembly. The distal assembly of the catheter consists of an imaging assembly, a rotating cutter, an apposition jog, and a flexible, tiltable nosecone with a radiopaque fuel gauge. The distal end of the catheter includes an approximately 13 cm length guidewire lumen, accommodating standard 0.014” guidewires. The nosecone component of the catheter is 6 cm long. The catheter is sterilized by electron beam and is intended for single use only. FDA UDI

Identifiers

Catalog Number
A110-LV FDA UDI
Primary DI / UDI-DI
00851354004578 FDA UDI
510(k) Number
K230005 FDA UDI
FDA Product Code
MCW FDA UDI
GMDN Term
Mechanical atherectomy system catheter, peripheral FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4875 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mechanical atherectomy system catheter, peripheral

Pantheris LV by Avinger, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical atherectomy system catheter, peripheral.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avinger, Inc.

Sources (1)

  • FDA UDI b303be41-845c-43b7-b16f-39c0f650d7b3 36 fields · synced Jun 8, 2026