Duns Number:003152968
Device Description: "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device "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. "
Catalog Number
E550
Brand Name
Kittykat II
Version/Model Number
E550
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
K120273
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
0375f0d8-7af8-47b3-8ec3-3c1ded1ec23a
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 |