Identifiers
- 510(k) Number
- K102484 FDA 510(k)
- FDA Product Code
- MMX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5150 FDA 510(k)
- Regulation Number
- 870.5150 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sequre Snare System is a percutaneous retrieval device designed for the removal of intravascular emboli, thrombi, or foreign bodies within the cardiovascular system. Classified as a Class II medical device, it employs a flexible snare mechanism to safely capture and extract occlusive materials from blood vessels, aiding in the restoration of blood flow during interventional procedures.
This system is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under the Medical Specialty of Cardiovascular and regulation number 870.5150. It is intended for use in clinical settings such as catheterization labs, where it is deployed via a catheter-based approach. The device is non-MRI compatible and must be handled with sterile technique, stored in its original packaging until use, and disposed of appropriately after a single application to ensure patient safety and infection control.
Frequently asked questions
What types of obstructions can the Sequre Snare System remove from blood vessels?
The Sequre Snare System is specifically designed for the percutaneous retrieval of intravascular emboli, thrombi, or foreign bodies within the cardiovascular system. Its flexible snare mechanism allows it to safely capture and extract occlusive materials, helping to restore blood flow during procedures like thrombolysis or embolism removal.
Is the Sequre Snare System reusable, or is it intended for single-use only?
The Sequre Snare System is explicitly intended for single-use only. This design ensures patient safety and infection control, as it must be disposed of after one application and should never be reused.
How should the Sequre Snare System be stored before use, and what precautions should be taken?
The device must be stored in its original, sterile packaging until use. Since it is non-MRI compatible and requires sterile handling, it should remain unopened and protected from contamination until deployment in a catheterization lab or similar clinical setting.
What regulatory pathway was followed for FDA clearance of the Sequre Snare System?
The Sequre Snare System received FDA clearance through a 510(k) submission, classified as a Class II medical device under the Medical Specialty of Cardiovascular. The clearance was granted under regulation number 870.5150, with a decision described as ‘Substantially Equivalent’ by the Cardiovascular (CV) advisory committee.
Can the Sequre Snare System be used in patients who require MRI imaging afterward?
No, the Sequre Snare System is explicitly labeled as non-MRI compatible. This means it should not be used in procedures where subsequent MRI imaging is planned, as the device could interfere with or be unsafe in an MRI environment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K102484 | Class II | Active |
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Manufacturer
- Manufacturer
- Lifetech Scientific (Shenzhen) Co., Ltd.
Sources (2)
- FDA 510(k) K102484 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026