Ventriculostomy Kit – European
KIT 46154 Vntrc Euro
2manufacturers in China registered for this device type
1catalogue number
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 |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Medtronic PS Medical, United States |
|---|---|
| FDA product code | HBG |
| Device type | Drills, Burrs, Trephines & Accessories (Manual) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4300 |
| 510(k) | K915546 |
| Record published | 2016-06-13 |
| Record revised | 2021-09-20 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 46154 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 508 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 172 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 65 |
| Drills, Burrs, Trephines & Accessories (Manual) | Synthes Gmbh | 34 |
| Integra® | Integra Pain Management | 7 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 6 |
| Symmetry Hudson | Aspen Surgical Products, Inc. | 5 |
| Symmetry Cushing | Aspen Surgical Products, Inc. | 4 |
| V. Mueller | Steris Corporation | 3 |
| SmartTip | ClearPoint Neuro Inc. | 3 |
| Drill Bit | Neurovention, LLC | 2 |
| Codman® | Integra LifeSciences Production Corporation | 2 |
Showing 12 of 41. All products under Drills, Burrs, Trephines & Accessories (Manual)
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medtronic Neurosurgery | 510(k) number | 2026-06-17 | Class II | Process control | Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin e | 167 |
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.