Device Dossier
Aptus TourGuide Steerable Guiding Sheath - Catheter, intravascular, guiding
Device Dossier for Aptus TourGuide Steerable Guiding Sheath - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor…
- GMDN category: Catheter, intravascular, guiding
Intended purpose
The steerable sheath, model TourGuide is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac or other peripheral placements. Do not use this device for neural placements.
Functional description
The device features an adjustable tip through use of a rotating collar that allows the physician to deflect the distal tip section of the sheath. It has a hemostatic valve, sideport with stopcock, radiopaque distal tip, contains side flush portholes and is deflectable by rotating the collar on the handle. The dilator has depth markings and snap locks onto the sheath; it has a tapered distal tip and an inner lumen recommended for use with 0.035” to 0.038” guidewire and/or transseptal needle.