Wildcat E400

GUDID 00851354004028

"The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to faciliate 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 Wildcat CTO Catheter is a 6F sheath and 0.035"" guidewire compatible over-the-wire device. It consists of a catheter shaft with a handle assembly at the porximal end and an atraumatic Distal Tip. A locking Luer connector 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. At the Slider’s most proximal location, the Wedges are in the retracted position. At the mid-point location, the Wedges are deployed. Moving the slider distal from this point initiates deflection of the Distal Tip. The amount of tip deflection increases with distal movement of the slider. At the most distal location, the Wedges remain fully deployed and the Distal Tip is at maximum deflection. The deployment and retraction of the Wedges as well as the deflection of the Distal Tip is visible under fluoroscopic guidance. The handle assembly consists of a Handle Body, Rotator, Tip Indicator, Slider, 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. Rotational movement of the Distal Tip can be achieved either with Wedges deployed or retracted. Luer is provided to facilitate fluid flush and the entry/exit of the guidewire. "

AVINGER, INC.

Mechanical atherectomy system catheter, peripheral
Primary Device ID00851354004028
NIH Device Record Key1c509c09-1f04-489d-907f-f0989764bbf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameWildcat
Version Model NumberE400
Catalog NumberE400
Company DUNS003152968
Company NameAVINGER, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-241-7030
Emailtlawson@avinger.com
Phone650-241-7030
Emailtlawson@avinger.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851354004028 [Primary]

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00851354004028]

Radiation Sterilization


[00851354004028]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-29
Device Publish Date2019-03-21

On-Brand Devices [Wildcat]

00851354004028"The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels
00851354004004"The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels

Trademark Results [Wildcat]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WILDCAT
WILDCAT
98646107 not registered Live/Pending
1017694 CANADA INC
2024-07-12
WILDCAT
WILDCAT
98232567 not registered Live/Pending
Akron Brass Company
2023-10-20
WILDCAT
WILDCAT
98012103 not registered Live/Pending
PARSONS XTREME GOLF, LLC
2023-05-24
WILDCAT
WILDCAT
97742609 not registered Live/Pending
Wildcat, LLC
2023-01-05
WILDCAT
WILDCAT
97742580 not registered Live/Pending
Wildcat, LLC
2023-01-05
WILDCAT
WILDCAT
97738667 not registered Live/Pending
WILSON CHRISTOPHER C
2023-01-01
WILDCAT
WILDCAT
97526310 not registered Live/Pending
Martin Bowles
2022-07-29
WILDCAT
WILDCAT
90561926 not registered Live/Pending
Wildcat PPE
2021-03-05
WILDCAT
WILDCAT
90318780 not registered Live/Pending
DVIGear, Inc.
2020-11-13
WILDCAT
WILDCAT
90279982 not registered Live/Pending
Shenzhen Shengdatong Technology Development Co., Ltd.
2020-10-27
WILDCAT
WILDCAT
90264428 not registered Live/Pending
Shenzhen Shengdatong Technology Development Co., Ltd.
2020-10-19
WILDCAT
WILDCAT
90139151 not registered Live/Pending
Sugar & Ice Creamery
2020-08-26

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