G56623

Cook Formula 418 Balloon Expandable Renal Stent: 5mm x 16mm x 135cm

$99.00 box of 1

Out of stock

Expiration: Expired

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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 418® Renal Balloon-Expandable Stent

G56623 / FOR418-18-135-5-16

  • Accepts Wire Guide: 0.018"
  • Stent Diameter: 5mm
  • Stent Length: 16mm
  • 135cm OTW
  • 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

5.00mm

Arms

N/A

Manufacturer

Stent Length

16mm

Unit

box of 1

Usable Length

135cm

  • 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.

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