Cook Formula 414 Rx Renal Balloon Expandable Stent: 4mm x 16mm x 80cm
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The item listed above is expired and may be used for educational, training, and non-clinical research purposes only. Any product information appearing below, including the product indication statement, pertains to an in-date item only.
Description
Formula™ 414 RX Renal Balloon-Expandable Stent
G18524 / FORX414-14-80-4-16
- Accepts Wire Guide: 0.014"
- Stent Diameter: 4mm
- Stent Length: 16mm
- 80cm Rapid-Exchange
- Sheath / Guiding Catheter: 5F / 6F
- Nominal / Rated Burst Pressure: 8/12atm
Indicated for use in patients with atherosclerotic disease of the renal arteries following suboptimal percutaneous transluminal renal angioplasty (PTRA) of a de novo or restenotic lesion (≤ 18 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0-7.0 mm. Suboptimal PTRA is defined as ≥ 50% residual stenosis, ≥ 20 mm Hg systolic or ≥ 10 mm Hg mean translesional pressure gradient or flow-limiting dissection.
Additional information
| Size | 4.00mm |
|---|---|
| Arms | N/A |
| Manufacturer | |
| Stent Length | 16mm |
| Unit | box of 1 |
| Usable Length | 80cm |
- FDA Product Code: NIN
- FDA Product Code Name: STENT, RENAL
- GMDN Term Code: 47932
- GMDN Term Name: Peripheral artery stent, bare-metal
- GMDN Term Description: A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.
