pRESET® Lite Thrombectomy Device (3mm X 20mm)
pRESET LITE is a mechanical thrombectomy device used to remove blood clots from large intracranial vessels during treatment of acute ischemic stroke. Its retrieval structure engages the…
pRESET LITE is a mechanical thrombectomy device used to remove blood clots from large intracranial vessels during treatment of acute ischemic stroke. Its retrieval structure engages the clot so that it can be withdrawn from the vessel.
The device has a nitinol retrieval structure connected to a push wire, with radiopaque platinum-iridium markers. The listed version has a 3 mm diameter and 20 mm working length. An introducer and tubing support delivery of the device.
Listed Item
The pRESET® LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing ischemic stroke due to acute vessel occlusion with thrombus.
Treatment Conditions
Use within six hours includes patients with persistent proximal anterior circulation occlusion and a smaller infarct core who first received thrombolysis. The indication also covers large intracranial vessel occlusion within eight hours when patients are ineligible for thrombolysis or it has failed.
Who Else Makes It
All of them in Shanghai. 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 |
Record
| Listed by | Phenox Limited, Ireland |
|---|---|
| FDA product code | POL |
| Device type | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5600 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K231539 |
| Record published | 2023-11-13 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRE-LT-3-20 | 3mm x 20mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Solitaire™ X-Pack | Micro Therapeutics, Inc. | 11 |
| Solitaire ™ Platinum | Micro Therapeutics, Inc. | 9 |
| Solitaire™ | Micro Therapeutics, Inc. | 5 |
| Solitaire™ X | Micro Therapeutics, Inc. | 5 |
| pRESET® Lite Thrombectomy Device (4mm x 20mm) | Phenox Limited | 1 |
| Trevo NXT | Stryker GmbH | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242676 | 2025-02-28 |
| K231539 | 2023-10-21 |
| K222848 | 2023-01-20 |
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.