Advertisement
Advertisement
May 30, 2023
Demax’s Introducer Sheath Kits Cleared by FDA
May 30, 2023—Demax Group, a China-based developer of cardiovascular devices for interventional procedures, announced that the company’s introducer sheath kits have received FDA 510(k) clearance in the United States.
According to Demax, this vascular sheath provides a channel for the introduction of balloon dilatation catheters, guidewires, or other instruments. The device is designed with a tapered tip and wrapped tightly with the guidewire to avoid fish mouths and improve pass-ability. The design ensures a smooth transition between the sheath tip and the dilator, thereby effectively reducing blood vessel damage.
Additionally, the company noted that the ultraviolet-curing coating technology is adopted for greater coating stability and the tip of the dilator provides good puncture support. It is suitable for hydrophilic-coated polymer guidewires or steel guidewires to suit different clinical preferences.
The Demax Group, which was established in 2004, consists of Australia Demax Medical, Beijing Demax Medical, and Tianjin Demax Medical.
Advertisement
Advertisement
