Ocelot PIXL P135

GUDID 00851354004141

"The Ocelot PIXL System consists of the Ocelot PIXL Catheter (“Ocelot PIXL”), the Lightbox console (“Lightbox”), and the Lightbox Umbilical (“Umbilical”). This system combines the use of Avinger’s peripheral catheter designs and an Optical Coherence Tomography (OCT) intravascular orientation and imaging tool. The Ocelot PIXL System is intended to cross chronic total occlusions in the peripheral vasculature while simultaneously providing OCT visualization to help orient the distal tip of the Ocelot PIXL to support the primary intended use. Use of Ocelot PIXL in conjunction with Lightbox allows for OCT imaging as an adjunct to fluoroscopy which facilitates intravascular orientation of the catheter. See Lightbox Operator’s Manual and Umbilical IFU for guidance on setting up and using the Lightbox and Umbilical, respectively. Ocelot PIXL is available in 2 different lengths, 135cm working length and 150cm working length.Ocelot PIXL is an over-the-wire device compatible with a 5F sheath and 0.014” guidewire. It consists of a catheter shaft with handle assembly at the proximal end and a distal tip designed to cross CTOs. A locking luer connecter at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire (i.e., Lumen Flush Port). The catheter is sterilized by ethylene oxide and is intended for single use only. "

AVINGER, INC.

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00851354004141
• NIH Device Record Key: 3966087a-a15b-44f0-a3b3-56a80e06d26b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ocelot PIXL
• Version Model Number: P135
• Catalog Number: P135
• Company DUNS: 003152968
• Company Name: AVINGER, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 650-241-7030
• Email: tlawson@avinger.com
• Phone: 650-241-7030
• Email: tlawson@avinger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851354004141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123532

FDA Product Code

• PDU: Catheter For Crossing Total Occlusions

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00851354004141]

Ethylene Oxide

[00851354004141]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-29
• Device Publish Date: 2019-03-21

Devices Manufactured by AVINGER, INC.

• 00851354004509 - Lightbox L3: 2024-02-06 The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the de
• 00851354004578 - Pantheris LV: 2024-02-06 The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F
• 00851354004554 - Tigereye ST: 2023-08-01 The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions
• 00851354004493 - Tigereye: 2023-03-22 The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (inclu
• 00851354004417 - Pantheris SV: 2019-08-12 The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature
• 00851354004004 - Wildcat: 2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to
• 00851354004028 - Wildcat: 2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to
• 00851354004042 - Kittykat II: 2019-03-29 "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It