EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING

Primary DI

00850004312001

Brand

EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING

Company

FREUDENBERG MEDICAL, LLC

Model

668782-100

Catalog number

PN1007960-100

Device description

The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable introducer sheath and dilator that is inserted into the peripheral vasculature to support the introduction of diagnostic or interventional devices, while minimizing blood loss associated with such insertions. The EMPOWER™ Introducer Sheath is coil-reinforced and coated with a lubricious hydrophilic coating. The EMPOWER™ hemostasis valve is integrated into the sheath hub and features a variable aperture seal for enhanced control over device insertion while maintaining hemostasis. The valve is normally closed until the user squeezes the actuator levers to proportionally open the valve and receive any device up to its labeled size. A sideport extends from the EMPOWER™ valve housing with a 3-way stopcock. The radiopaque dilator is designed to accommodate an .035” (0.89mm) guidewire and includes a proximal hub grip with a female luer taper fitting for flushing. Prior to insertion, the dilator hub can be secured to the EMPOWER™ housing with a quarter-turn twist.

Published

2021-06-15

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

OTC

false

Sterile

true

Single use

true