Duns Number:529864170
Device Description: The SeQureTM Snare System consists of a snare, a catheter, a loader and a torquer. The sna The SeQureTM Snare System consists of a snare, a catheter, a loader and a torquer. The snare is constructed of a nitinol shaft and a loop with the plane of the loop perpendicular to the nitinol shaft. The nitinol loop is covered with a tungsten coil which is coated by laminated titanium and its nitride to enhance radiopaque. The pre-formed snare loop can be introduced through catheter without risk of permanent deformiation because of super-elasticity of nitinol material. The catheter consists of luer connector and PE tubing with a radiopaque markband at its distal tip to enhance the visibility during the operation. The snare is pre-assembled with the loader and the torque, and then packaged together with corresponding catheter.
Catalog Number
-
Brand Name
SeQureTM Snare System
Version/Model Number
LT-SG-35
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
K102484
Product Code
MMX
Product Code Name
Device, Percutaneous Retrieval
Public Device Record Key
252145e5-6ef5-4298-b6e5-628920689322
Public Version Date
July 08, 2021
Public Version Number
4
DI Record Publish Date
November 17, 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 |