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Pantheris SV

FDA UDI

Class II (US FDA UDI)

by Avinger, Inc.

Identity

Trade Name
Pantheris SV FDA UDI
Generic Name
Mechanical atherectomy system, coronary/peripheral FDA UDI
Device Name
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. FDA UDI
Model / Reference
A140-SV FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
A140-SV FDA UDI
Primary DI / UDI-DI
00851354004417 FDA UDI
510(k) Number
K182341 FDA UDI
FDA Product Code
NQQ FDA UDI
MCW FDA UDI
GMDN Term
Mechanical atherectomy system, coronary/peripheral FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
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

Yes

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
Sterilization Method
Radiation Sterilization FDA UDI

Category: Mechanical atherectomy system, coronary/peripheral

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

Similar devices

Also classified as Mechanical atherectomy system, coronary/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 75802b75-b0c6-4612-b342-d118b1801e07 36 fields · synced May 30, 2026