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 |
|---|---|
| DQY | Catheter, Percutaneous |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00851354004042 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00851354004042 | 00851354004042 | 851354004042 | 0851354004042 |
GMDN Terms#
| Term | Definition |
|---|---|
| Mechanical atherectomy system catheter, peripheral | A 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 |
|---|
| Radiation Sterilization |
Contacts#
| Phone | |
|---|---|
| 650-241-7030 | tlawson@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
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| 00851354004004 | Wildcat | W400 | W400 | 2019-03-21 |
| 00851354004028 | Wildcat | E400 | E400 | 2019-03-21 |
| 00851354004059 | Kittykat II | E550 | E550 | 2019-03-21 |
| 00851354004073 | Juicebox | J100 | J100 | 2019-03-21 |
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