Lynx Aspiration Catheter System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K254276 FDA 510(k)
- FDA Product Code
- NRY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lynx Aspiration Catheter System is a catheter, thrombus retriever designed for mechanical thrombectomy, a procedure used to remove blood clots from blood vessels. It is intended for use in neurovascular interventions to restore blood flow in patients experiencing acute ischemic stroke by aspirating thrombi (clots) from cerebral arteries. The device operates through a suction-based mechanism to clear occlusions while minimizing vessel trauma.
This system is supplied as a sterile, single-use device and is classified under FDA regulation number 870.1250 as a Class II medical device, with a Traditional 510(k) clearance under the Cardiovascular advisory committee. It is intended for use in hospital settings, specifically within interventional radiology or neurovascular suites, and is compatible with standard neurovascular workflows. The system includes multiple catheter sizes to accommodate varying vessel diameters, ensuring optimal vessel-to-catheter ratios for effective clot removal.
Frequently asked questions
What is the Lynx Aspiration Catheter System used for?
The Lynx Aspiration Catheter System is designed specifically for mechanical thrombectomy in neurovascular procedures. It removes blood clots (thrombi) from cerebral arteries to restore blood flow in patients suffering from acute ischemic stroke. The device employs a suction-based mechanism to clear blockages while reducing the risk of vessel damage, making it ideal for emergency interventions in hospital settings like interventional radiology or neurovascular suites.
How is the Lynx Aspiration Catheter System supplied, and is it reusable?
The Lynx Aspiration Catheter System is supplied as a sterile, single-use device. This ensures patient safety by eliminating the risk of cross-contamination between procedures. Single-use devices are also designed for convenience, as they do not require reprocessing or sterilization between uses, which is critical in time-sensitive stroke interventions.
What sizes are available for the Lynx Aspiration Catheter System, and why does this matter?
The Lynx Aspiration Catheter System includes multiple catheter sizes to match varying vessel diameters. This flexibility ensures an optimal vessel-to-catheter ratio, which is essential for effective clot removal without causing trauma to the vessel walls. Proper sizing improves procedural success and reduces complications during thrombectomy.
Where should the Lynx Aspiration Catheter System be stored, and how should it be handled?
The system should be stored in its original, sterile packaging until ready for use. It is designed for single-use only, so unopened devices should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage maintains sterility and device integrity, ensuring reliability during critical neurovascular procedures.
Is the Lynx Aspiration Catheter System compatible with standard neurovascular workflows?
Yes, the Lynx Aspiration Catheter System is explicitly designed to integrate seamlessly with standard neurovascular workflows. Its suction-based mechanism aligns with existing thrombectomy protocols, and its compatibility with hospital interventional suites ensures smooth incorporation into clinical practices. The device’s single-use nature also reduces logistical challenges, allowing clinicians to focus on patient care.
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. Sources consulted: Lynx | Q'Apel Medical Inc., Q'Apel Medical Announces U.S. Launch of the… | Q'Apel Medical Inc., Q'Apel Medical Announces U.S. Launch of the Lynx™ Aspiration Catheter ..., Q'Apel Medical Announces U.S. Launch of the… | Q'Apel Medical Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K254276 | Class II | Active |
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Manufacturer
- Manufacturer
- Q’Apel Medical, Inc.
- FDA Applicant
- QApel Medical, Inc.
Sources (1)
- FDA 510(k) K254276 24 fields · synced Oct 1, 2026