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.
Catalog Number
-
Brand Name
FuStarTM Steerable introducer
Version/Model Number
SVB7F-900
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
f83e4fbe-d2a6-4952-9335-9ee00f3fc734
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
November 14, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 90 |