Wildcat
- Primary DI
- 00851354004004
- Brand
- Wildcat
- Company
- AVINGER, INC.
- Model
- W400
- Catalog number
- W400
- Device description
- """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."
- 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 |
|---|---|---|---|---|
| 00851354004004 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00851354004004 | 00851354004004 | 851354004004 | 0851354004004 |
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
Other Devices From This Company#
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|---|---|---|---|---|
| 00851354004417 | Pantheris SV | A140-SV | A140-SV | 2019-08-02 |
| 00851354004189 | Ocelot III | O200 | O200 | 2019-03-21 |
| 00851354004233 | Ocelot IV | O250 | O250 | 2019-03-21 |
| 00851354004271 | CO2 | C100 | C100 | 2019-03-21 |
| 00851354004370 | Pantheris | A400 | A400 | 2019-03-21 |
| 00851354004387 | Pantheris | A400X | A400X | 2019-03-21 |
| 00851354004554 | Tigereye ST | O350 | O350 | 2023-07-24 |
| 00851354004493 | Tigereye | O300 | O300 | 2023-03-14 |
| 00851354004509 | Lightbox L3 | L300 | L300 | 2024-01-29 |
| 00851354004578 | Pantheris LV | LV | A110-LV | 2024-01-29 |
| 00851354004264 | Sterile Drape | SD100 | SD100 | 2019-03-21 |
| 00851354004028 | Wildcat | E400 | E400 | 2019-03-21 |
| 00851354004042 | Kittykat II | W550` | W550 | 2019-03-21 |
| 00851354004059 | Kittykat II | E550 | E550 | 2019-03-21 |
| 00851354004073 | Juicebox | J100 | J100 | 2019-03-21 |
| 00851354004127 | Lightbox Umbilical | U100 | U100 | 2019-03-21 |
| 00851354004141 | Ocelot PIXL | P135 | P135 | 2019-03-21 |
| 00851354004301 | Lightbox Umbilical | U250 | U250 | 2019-03-21 |
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|---|---|---|---|---|
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| 06934955914737 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
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