Kittykat II

Primary DI
00851354004042
Brand
Kittykat II
Company
AVINGER, INC.
Model
W550`
Catalog number
W550
Device description
"""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 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. The Kittycat 2 Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature.Kittycat 2 is intended to be used to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline or contrast."""
Published
2019-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851354004042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851354004042008513540040428513540040420851354004042

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy system catheter, peripheralA sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
650-241-7030tlawson@avinger.com

Regulatory Flags#

DUNS number
003152968
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851354004417Pantheris SVA140-SVA140-SV2019-08-02
00851354004189Ocelot IIIO200O2002019-03-21
00851354004233Ocelot IVO250O2502019-03-21
00851354004271CO2C100C1002019-03-21
00851354004370PantherisA400A4002019-03-21
00851354004387Pantheris A400XA400X2019-03-21
00851354004554Tigereye STO350O3502023-07-24
00851354004493TigereyeO300O3002023-03-14
00851354004509Lightbox L3L300L3002024-01-29
00851354004578Pantheris LVLVA110-LV2024-01-29
00851354004264Sterile DrapeSD100SD1002019-03-21
00851354004004WildcatW400W4002019-03-21
00851354004028WildcatE400E4002019-03-21
00851354004059Kittykat IIE550E5502019-03-21
00851354004073JuiceboxJ100J1002019-03-21
00851354004127Lightbox Umbilical U100U1002019-03-21
00851354004141Ocelot PIXLP135P1352019-03-21
00851354004301Lightbox Umbilical U250U2502019-03-21

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