Steerable Introducer Sheath 12F

Primary DI

00850004312049

Brand

Steerable Introducer Sheath 12F

Company

FREUDENBERG MEDICAL, LLC

Model

SS120065

Catalog number

PN1008533-004

Device description

The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.

Published

2020-01-13

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