Trevo XP
Trevo XP Provue Retriever
5manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | NRY |
| Device type | Catheter, Thrombus Retriever |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K132641 |
| Record published | 2016-09-21 |
| Record revised | 2026-01-21 (version 8) |
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 |
| Storage | Special storage condition: Store in cool, dry, dark place. |
| Sizes | Length 25 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90185 | Diameter: 4.0 Millimeter | In distribution |
| 90186 | Diameter: 6.0 Millimeter | 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 |
|---|---|
| K183464 | 2019-03-13 |
| K173841 | 2018-03-18 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Neurovascular | 510(k) number | 2017-11-28 | Class II | Packaging process control | Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack. | 2020-04-28 | |
| Stryker Neurovascular | 510(k) number | 2017-11-03 | Class II | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. | 2 units | 2019-11-04 |
| Stryker Neurovascular | 510(k) number | 2017-11-03 | Class II | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. | 2 units | 2019-11-04 |
| Stryker Neurovascular | 510(k) number | 2017-11-03 | Class II | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. | 1 unit | 2019-11-04 |
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.