FuStarTM Steerable introducer - The FuStarTM Steerable Introducers are designed - Lifetech Scientific (Shenzhen) Co., Ltd.

Duns Number:529864170

Device Description: The FuStarTM Steerable Introducers are designed to perform as a guiding shealth and/or in The FuStarTM Steerable Introducers are designed to perform as a guiding shealth and/or introducer sheath, which provides a pathway through whichdevices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Its low- profile design and atraumatic tip reduce the potential risk for trauma during percutaneous punctures while facilitating passage of a wide variety of cathelters and devices.The proposed introducer can give physicians good control during operation, the curl options are available at 30mm (Small) and 50mm(Large). Ineach option, there are 2 connector types which are luer lock connector and silicone valve connector, and several specifications combination Also, the visible knob with scale of controller facillitates the physicians to estimate the deflecting angle of the sheath while intra-operation.The products are available in different effective length (550mm, 700mm and 900mm) and diameter (French sie, 5F, 6F, 7F, 8F, 9F and 10F). The deflection angle of shealth is from 0 degree to 180 degree.

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More Product Details

Catalog Number

-

Brand Name

FuStarTM Steerable introducer

Version/Model Number

SVB5F-550

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

K100184

Product Code Details

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Device Record Status

Public Device Record Key

d71414a7-4210-4f29-b944-3be794019dfb

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

November 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 90