Matreneu® Percutaneous Balloon Compression Kit
Matreneu Percutaneous Balloon Compression Kit is used in a neurosurgical balloon-compression procedure for primary trigeminal neuralgia. It includes a balloon catheter, puncture needle,…
Matreneu Percutaneous Balloon Compression Kit is used in a neurosurgical balloon-compression procedure for primary trigeminal neuralgia. It includes a balloon catheter, puncture needle, syringe, connector and pressure gauge. The catheter carries a micro-balloon to the trigeminal region within Meckel’s cavity.
Placement uses a sheath under X-ray fluoroscopy. Contrast agent fills the balloon so its expansion applies compression at the treatment site. The pressure gauge and syringe form part of the kit used during balloon filling rather than a separate implanted therapy system.
Listed Item
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Use Setting and Supply
The kit is intended for use in a sterile operating room and is supplied sterile for single use. Sterilization uses ethylene oxide. Its indication is specifically the percutaneous balloon-compression procedure for primary trigeminal neuralgia, with the kit components supporting access and balloon inflation.
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Hotry Co., Ltd. | Beijing | Beijing | Manufacturer | 9 |
Record
| Listed by | Shenzhen Shineyard Medical Device Co., Ltd., China |
|---|---|
| FDA product code | HAO |
| Device type | Instrument, Surgical, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4535 |
| 510(k) | K220920 |
| Record published | 2023-06-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 86 to 106 KiloPascal; Handling environment humidity up to 93 % RH; Handling environment temperature -20 to 55 °C; Storage environment atmospheric pressure 86 to 106 KiloPascal; Storage environment humidity up to 93 % RH; Storage environment temperature -20 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PBCS-083513 | In distribution | |
| PBCS-128014 | In distribution | |
| PBCS-103513 | In distribution | |
| PBCS-125013 | In distribution | |
| PBCS-108014 | In distribution | |
| PBCS-088014 | In distribution | |
| PBCS-105013 | In distribution | |
| PBCS-105014 | In distribution | |
| PBCS-123513 | In distribution | |
| PBCS-088013 | In distribution | |
| PBCS-085015 | In distribution | |
| PBCS-083515 | In distribution | |
| PBCS-125015 | In distribution | |
| PBCS-125014 | In distribution | |
| PBCS-123514 | In distribution | |
| PBCS-108013 | In distribution | |
| PBCS-128013 | In distribution | |
| PBCS-085013 | In distribution | |
| PBCS-128015 | In distribution | |
| PBCS-103515 | In distribution | |
| PBCS-083514 | In distribution | |
| PBCS-085014 | In distribution | |
| PBCS-103514 | In distribution | |
| PBCS-123515 | In distribution | |
| PBCS-108015 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 705 |
| Ambler Surgical | Ambler Surgical, LLC | 597 |
| V. Mueller | Steris Corporation | 577 |
| Millennium | Avalign Technologies, Inc. | 383 |
| Avalign | Avalign Technologies, Inc. | 352 |
| Novo Surgical | Novo Surgical, Inc. | 300 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 283 |
| Boss Instruments | Boss Instruments, Ltd. | 263 |
| Pilling | Teleflex Medical LLC | 156 |
| Instrument, Surgical, Non-Powered | Karl Storz GmbH & Co. KG | 130 |
| Instrument, Surgical, Non-Powered | Fehling Instruments GmbH | 126 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 109 |
Showing 12 of 249. All products under Instrument, Surgical, Non-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220920 | 2022-09-07 |
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.