Product name
Core Product · CORE
Disposable Visualized Balloon Drainage Catheter
Registration No.: 湘械注准20242140780. Integrated real-time visualization and balloon-assisted drainage, moving ICH surgery from blind puncture to image-guided precision.
一次性使用可视球囊引流导管
Registration
湘械注准20242140780
Hunan NMPA cleared
Category
Neurosurgery · Single-use
Class III medical device
Usage
Single-patient · Sterile
Eliminates cross-contamination risk
Intended use · Indications
For visualized minimally invasive ICH drainage
Primary use
Minimally invasive ICH drainage
Real-time visualization-guided puncture and aspiration of intracerebral hematoma, with balloon-assisted drainage to reduce residual volume.
Indications
Hypertensive / traumatic ICH
Intraparenchymal hematomas (basal ganglia, thalamus, lobar, cerebellar) requiring minimally invasive drainage.
Key features
※ Features below are based on the registered product technical requirements and verifiable descriptions.
01 · Visualization
Real-time intra-operative imaging
Built-in imaging channel provides live visual feedback of hematoma and surrounding tissue.
02 · Balloon
Balloon-assisted drainage
Balloon structure supports controlled aspiration and drainage, reducing residual hematoma.
03 · Integration
Puncture + drainage in one
Puncture, imaging, and drainage integrated in a single catheter — fewer instrument changes.
04 · Single-use
Eliminates cross-contamination
Single-patient sterile packaging; opened and used, reducing infection risk from reuse.
Clinical value
A new option for primary-hospital ICH emergency care
Primary hospitals
"See-what-you-do" minimally invasive surgery
Enables county-level hospitals to perform visualized ICH drainage, lowering the experience barrier.
Efficiency
Shorter procedures
Visualization-guided puncture reduces blind passes and re-exploration, with significantly shorter OR time than conventional craniotomy.
Related cases
Real clinical-use records
Cases documented across tertiary hospitals including Xiangya Hospital, Hunan Provincial People's Hospital, Tongji Hospital, Baise Tianyang County People's Hospital, and the First Affiliated Hospital of Nanchang University — all de-identified and authorized.
Related products
Companion products from the same line
Companion 1
Disposable Tissue Retractor & Dilator Catheter →
Tissue retraction and working-channel establishment in neurosurgery.
Companion 2
Disposable Visualized Tissue Puncture & Dilator Catheter →
Visualization-guided tissue puncture and stepwise dilation.
※ Product information on this page is based on the Hunan NMPA registration certificate (湘械注准20242140780). Product name, registration number, and packaging shall be subject to the actual product packaging and instructions. Use must strictly follow physician guidance and the product instructions. Clinical data are drawn from authorized cases and public academic materials; unverified content is not to be used as formal product claims.