SeQureTM Snare System
The SeQure Snare System retrieves and manipulates foreign objects within the cardiovascular system. It combines a snare with a delivery catheter, a loader and a torquer for positioning the…
The SeQure Snare System retrieves and manipulates foreign objects within the cardiovascular system. It combines a snare with a delivery catheter, a loader and a torquer for positioning the snare during the procedure.
The snare has a nitinol shaft and a preformed loop positioned perpendicular to it. Nitinol’s superelasticity allows the loop to pass through the catheter without permanently losing its shape. A tungsten coil around the loop, coated with titanium and titanium nitride, makes it visible on X-ray.
Listed Item
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.
Catheter and Assembly
The catheter uses polyethylene tubing with a proximal Luer connector and a radiopaque marker band at its distal tip. The snare comes preassembled with the loader and torquer and is packaged with its corresponding catheter.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifetech Scientific (Shenzhen) Co,.ltd | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Lifetech Scientific (Shenzhen) Co,.ltd, China |
|---|---|
| FDA product code | MMX |
| Device type | Device, Percutaneous Retrieval |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Manufacturer |
| 510(k) | K102484 |
| Record published | 2017-11-17 |
| Record revised | 2021-07-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LT-SG-25 | In distribution | |
| LT-SM-07 | In distribution | |
| LT-SM-02 | In distribution | |
| LT-SG-35 | In distribution | |
| LT-SM-04 | In distribution | |
| LT-SP-25 | In distribution | |
| LT-SG-20 | In distribution | |
| LT-SG-05 | In distribution | |
| LT-SG-30 | In distribution | |
| LT-SG-10 | In distribution | |
| LT-SP-10 | In distribution | |
| LT-SG-15 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ONE Snare® | Merit Medical Systems, Inc. | 29 |
| EN Snare® | Merit Medical Systems, Inc. | 17 |
| Expro Elite | Teleflex Medical LLC | 10 |
| Halo™ Single Loop Snare Kit | Argon Medical Devices, Inc. | 9 |
| Atrieve™ Vascular Snare Kit | Argon Medical Devices, Inc. | 7 |
| Halo™ Single-Loop Microsnare Kit | Argon Medical Devices, Inc. | 6 |
| Expro Elite™ snare | Vascular Solutions LLC | 5 |
| Amplatz Goose Neck™ | Medtronic, Inc. | 5 |
| Sympro Elite | Teleflex Medical LLC | 5 |
| Quattro Elite™ snare | Vascular Solutions LLC | 5 |
| Sympro Elite™ snare | Vascular Solutions LLC | 5 |
| Empower™ | Merit Medical Systems, Inc. | 4 |
Showing 12 of 26. All products under Device, Percutaneous Retrieval
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102484 | 2010-11-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.