Device Dossier
Extra Large Check-Flo Introducer - Vascular catheter introduction set, nonimplantable
Device Dossier for Extra Large Check-Flo Introducer - Vascular catheter introduction set, nonimplantable (Vascular catheter introduction set,…
- GMDN category: Vascular catheter introduction set, nonimplantable
Intended purpose
The intended purpose of these devices is to serve as an introducer or guiding sheath to establish a pathway for other devices to be placed in the central circulatory system. The introducer is not intended to be placed in the coronary or neuro vasculature.
Functional description
These devices include a sheath and one dilator. The sheaths are available in various lengths. The sheath is made of radiopaque material. The dilator tip extends past the sheath to facilitate introduction and positioning of the introducer assembly. The proximal end of the sheath is comprised of a check-flo hemostasis valve which accepts a range of devices while minimizing blood reflux, as well as a stopcock on the side-arm.