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Ocelot IV

FDA UDI

Class II (US FDA UDI)

by Avinger, Inc.

Identity

Trade Name
Ocelot IV FDA UDI
Generic Name
Mechanical atherectomy system, coronary/peripheral FDA UDI
Device Name
The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires 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. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature. FDA UDI
Model / Reference
O250 FDA UDI
Description
The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires 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. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature. FDA UDI

Identifiers

Catalog Number
O250 FDA UDI
Primary DI / UDI-DI
00851354004233 FDA UDI
510(k) Number
K123462 FDA UDI
FDA Product Code
PDU FDA UDI
GMDN Term
Mechanical atherectomy system, coronary/peripheral FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Mechanical atherectomy system, coronary/peripheral

Ocelot IV 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 27cf8def-ae4b-4da5-b567-72d63fd358d1 36 fields · synced Jun 8, 2026