Lynx Aspiration Catheter System
Lynx is an aspiration catheter for removing thrombus from intracranial vessels with compatible tubing and a suction pump. It has a variable-stiffness single lumen, hydrophilic coating,…
Lynx is an aspiration catheter for removing thrombus from intracranial vessels with compatible tubing and a suction pump. It has a variable-stiffness single lumen, hydrophilic coating, distal radiopaque marker and proximal Luer hub. A guide catheter or long sheath provides access for navigation to the occlusion.
Treatment is indicated within eight hours of acute ischemic stroke onset for large-vessel occlusion in specified carotid, middle cerebral M1 or M2, basilar or vertebral arteries. Candidates include patients ineligible for thrombolytic therapy or those whose thrombolytic treatment failed.
Listed Item
Lynx Aspiration Catheter System 044, 145cm
Coaxial Use and Supply
Different lengths and diameters support individual or coaxial use; in a coaxial setup, aspiration is applied only through the inner catheter. The package includes a hemostasis valve, aspiration tubing with flow switch and extension, and a scale card. Devices are supplied sterile for single use.
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
Record
| Listed by | Q’apel Medical, Inc., United States |
|---|---|
| FDA product code | NRY |
| Device type | Catheter, Thrombus Retriever |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Manufacturer |
| 510(k) | K254276 |
| Record published | 2026-05-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AC4044-145-S | In distribution | |
| AC4044-160-S | In distribution | |
| AC6072-132-S | In distribution | |
| AC5058-138-S | In distribution | |
| AC5058-149-S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penumbra System | Penumbra Inc. | 100 |
| RED 43 | Penumbra Inc. | 18 |
| Solitaire™ X-Pack | Micro Therapeutics, Inc. | 14 |
| ACE | Penumbra Inc. | 14 |
| Raptor Aspiration Catheter | Balt USA, LLC | 13 |
| Cereglide | Cerenovus, Inc. | 13 |
| Solitaire™ | Micro Therapeutics, Inc. | 9 |
| Solitaire™ X | Micro Therapeutics, Inc. | 9 |
| RED 68 | Penumbra Inc. | 9 |
| Riptide™ | Micro Therapeutics, Inc. | 9 |
| Zoom™ Reperfusion Catheter | Imperative Care Inc. | 9 |
| CaptureTM | Micro Therapeutics, Inc. | 8 |
Showing 12 of 80. All products under Catheter, Thrombus Retriever
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254276 | 2026-05-07 |
| K222786 | 2023-08-25 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-02-26 | Class I | Device Design | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur. | 1617 |
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.