Stent retrievers
Solitaire X-PACK
A device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device.
Solitaire X-PACK models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| XPACK200 | — | Not stated | Available |
| XPACK201 | — | Not stated | Available |
| XPACK202 | — | Not stated | Available |
| XPACK203 | — | Not stated | Available |
| XPACK204 | — | Not stated | Available |
| XPACK205 | — | Not stated | Available |
| XPACK206 | — | Not stated | Available |
| XPACK207 | — | Not stated | Available |
| XPACK208 | — | Not stated | Available |
| XPACK209 | — | Not stated | Available |
| XPACK213 | — | Not stated | Available |
| XPACK214 | — | Not stated | Available |
| XPACK215 | — | Not stated | Available |
| XPACK216 | — | Not stated | Available |
| XPACK217 | — | Not stated | Available |
| XPACK300 | — | Not stated | Available |
| XPACK301 | — | Not stated | Available |
| XPACK302 | — | Not stated | Available |
| XPACK303 | — | Not stated | Available |
| XPACK304 | — | Not stated | Available |
| XPACK305 | — | Not stated | Available |
| XPACK306 | — | Not stated | Available |
| XPACK307 | — | Not stated | Available |
| XPACK308 | — | Not stated | Available |
| XPACK309 | — | Not stated | Available |
| XPACK313 | — | Not stated | Available |
| XPACK314 | — | Not stated | Available |
| XPACK315 | — | Not stated | Available |
| XPACK316 | — | Not stated | Available |
| XPACK317 | — | Not stated | Available |
| XPACK318 | — | Not stated | Available |
| XPACK319 | — | Not stated | Available |
| XPACK320 | — | Not stated | Available |
| XPACK321 | — | Not stated | Available |
| XPACK322 | — | Not stated | Available |
| XPACK323 | — | Not stated | Available |
| XPACK324 | — | Not stated | Available |
| XPACK325 | — | Not stated | Available |
| XPACK326 | — | Not stated | Available |
| XPACK327 | — | Not stated | Available |
| XPACK331 | — | Not stated | Available |
| XPACK332 | — | Not stated | Available |
| XPACK333 | — | Not stated | Available |
| XPACK334 | — | Not stated | Available |
| XPACK335 | — | Not stated | Available |
| XPACK336 | — | Not stated | Available |
| XPACK337 | — | Not stated | Available |
| XPACK338 | — | Not stated | Available |
| XPACK339 | — | Not stated | Available |
| XPACK340 | — | Not stated | Available |
| XPACK341 | — | Not stated | Available |
| XPACK342 | — | Not stated | Available |
| XPACK343 | — | Not stated | Available |
| XPACK344 | — | Not stated | Available |
| XPACK345 | — | Not stated | Available |
| XPACK346 | — | Not stated | Available |
| XPACK347 | — | Not stated | Available |
FDA clearances
- 510(k) K183022 January 2019
- 510(k) K182097 November 2018
- 510(k) K180715 July 2018
- 510(k) K180959 June 2018
- 510(k) K091559 September 2009
Procedures that use stent retrievers
Frequently asked questions
What is Solitaire X-PACK used for?
A device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device.
Who makes Solitaire X-PACK?
Solitaire X-PACK is made by Micro Therapeutics, Inc.. It is listed under stent retrievers for stroke in our device library.
What sizes does Solitaire X-PACK come in?
The FDA device database does not list sizes for Solitaire X-PACK. Check the instructions for use or ask a Micro Therapeutics, Inc. representative.
Is Solitaire X-PACK MRI safe?
The FDA device database entry for Solitaire X-PACK does not state its MRI safety status. Check the labeling before MRI.
Is Solitaire X-PACK FDA cleared?
Solitaire X-PACK is covered by FDA submissions K091559, K182097, K183022, K180715, K180959.
How do I contact a Micro Therapeutics, Inc. sales representative?
Micro Therapeutics, Inc. has not listed representatives on LA Vascular yet. Visit the Micro Therapeutics, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.