Steerable Introducer Sheath 8.5F Medium Curl - The Steerable introducer sheath consists of a - FREUDENBERG MEDICAL, LLC

Duns Number:790487263

Device Description: The Steerable introducer sheath consists of a steerable sheath connected to a handle with 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.

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More Product Details

Catalog Number

PN1008533-002

Brand Name

Steerable Introducer Sheath 8.5F Medium Curl

Version/Model Number

SS085075M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191190

Product Code Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

fc3be494-8877-412b-a085-48389f5ec8bf

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

October 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FREUDENBERG MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5