Device Dossier

EXTRA SAFE Percutaneous dilator sheaths - Fascial tissue dilator, single-use

Device Dossier for EXTRA SAFE Percutaneous dilator sheaths - Fascial tissue dilator, single-use (Fascial tissue dilator, single-use, Class III, sponsor…

Intended purpose

EXTRA SAFE sheaths are intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

Functional description

Composed of high-strength and flexible plastic sheaths can be used individually or telescopically for the extraction of implanted leads. Each sheath has a colour that allows its immediate identification based on the diameter. The sheaths are marked with a radiopaque material in order to be clearly visible under fluoroscopy.

TGA Public Summary