Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
Micro Therapeutics Inc. d/b/a ev3 NeurovascularThe Rist Radial Access Catheter family consists of single lumen catheters designed to provide access to peripheral, coronary, and neuro vasculature. These catheters assist clinicians in delivering interventional devices and diagnostic agents, particularly in neurovascular procedures, improving access with features like hydrophilic coatings and radiopaque markers for better visualization under fluoroscopy.
Intended Use
The Rist™ Radial Access Catheter family is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The Radial Access Selective Catheter can also facilitate introduction of diagnostic agents in the neuro vasculature but is not intended for diagnostic agents in coronary or peripheral arteries.
Technology
The devices are single lumen catheters with reinforced shafts (stainless steel and nitinol), radiopaque marker bands for visualization, hydrophilic coating on the distal 25 cm of the guide catheters to reduce insertion force, PTFE-lined lumen for reduced friction, and are supplied sterile for single use. The tapered shaft of the selective catheter is radiopaque with Simmons 2 or Berenstein shapes at the distal tip.
Performance
Non-clinical bench testing including in-vitro simulated use studies per ANSI/AAMI HE75:2009/(R) 2018 demonstrated the devices meet acceptance criteria, supporting substantial equivalence to predicate devices. No clinical or animal testing was required due to unchanged indications, materials, and fundamental technology.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/15/2024
7 months - 2
FDA Approval
1/2/2025
Other devices from Micro Therapeutics Inc. d/b/a ev3 Neurovascular
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