Duns Number:003152968
Device Description: "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral v "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 Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature. The Wildcat Catheter 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.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.
Catalog Number
W400
Brand Name
Wildcat
Version/Model Number
W400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
8314c5bb-9f03-4596-962c-ee2538c5e907
Public Version Date
March 29, 2019
Public Version Number
1
DI Record Publish Date
March 21, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |