Kittykat II E550

GUDID 00851354004059

"Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It consists of a catheter shaft with handle assembly at the proximal end and an atraumatic Distal Tip. A locking Luer connecter at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.The Distal Tip houses Spiral Flutes and allows atraumatic advancement of the catheter through the vasculature. The pre-shaped Distal Tip is made of a malleable material and may be reshaped as needed by the user. The deflection of the Distal Tip is visible under fluoroscopic guidance. The handle assembly consists of a Handle Body, Rotator, and Luer. The Handle Body controls rotational orientation of the catheter, including the flexible Distal Tip. The Rotator controls the rotational movement of the Distal Tip, independent of the catheter orientation. The Luer is provided at the proximal end to facilitate fluid flush and the entry/exit of the guidewire. Kittycat 2 is intended to create a channel in totally occluded peripheral vessels. The device may also be used 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. "

AVINGER, INC.

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00851354004059
• NIH Device Record Key: 0375f0d8-7af8-47b3-8ec3-3c1ded1ec23a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kittykat II
• Version Model Number: E550
• Catalog Number: E550
• 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	00851354004059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120273

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

[00851354004059]

Radiation Sterilization

[00851354004059]

Radiation Sterilization

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

On-Brand Devices [Kittykat II]

• 00851354004059: "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with
• 00851354004042: "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with