Wildcat

"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…

Registry build 21.09.26

“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. “

14manufacturers in China registered for this device type
2catalogue numbers in this listing
5510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DQY
Manufacturer City Province Registered as Device types
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Covidien Medical Products (Shanghai) Manufacturing LLC Shanghai Shanghai Contract manufacturer 8
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Goals Sterilization Co., Ltd. Jiaxing Zhejiang Contract manufacturer 26
Wuxi Goals Medical Technology Co., Ltd. Yixing Jiangsu Contract manufacturer 24
Suzhou Zenith Vascular Scitech Limited Suzhou Jiangsu Manufacturer 6
Haolang Technology (Foshan) Limited Corporation Foshan Guangdong Contract manufacturer 6
OrbusNeich Medical (Shenzhen) Co., Ltd. Shenzhen Guangdong Complaint-file establishment 5
Curatia Medical Limited Suzhou Jiangsu Specification developer 5
Shanghai Wallaby Medical Technologies Co., Inc. Shanghai Shanghai Contract manufacturer 5
DK Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 3

Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous

Record

Regulatory record for Wildcat
Listed by Avinger, Inc., United States
FDA product code DQY
Device type Catheter, Percutaneous
Device class Class 2
Regulation 21 CFR 870.1250
Record published 2019-03-21

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Wildcat
Catalogue number Size Status
W400 In distribution
E400 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Launcher™ Medtronic, Inc. 3,805
Sherpa NX Balanced™ Medtronic, Inc. 1,523
Arrow Teleflex Medical LLC 1,249
Z2 Medtronic, Inc. 955
Vista Brite TIP Cordis Corp. 789
Mach1™ Boston Scientific Corporation 777
Sherpa NX Active Medtronic, Inc. 571
Zuma® Medtronic, Inc. 569
Convey Pendracare International B.V. 532
Taiga Medtronic, Inc. 307
RunWay™ Boston Scientific Corporation 300
ConcierGE Guiding Excellence™ Merit Medical Systems, Inc. 295

Showing 12 of 500. All products under Catheter, Percutaneous

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K112579 2011-10-06
K111704 2011-09-09
K101647 2010-08-06
K102022 2010-08-06
K083313 2009-02-02

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer