Medtronic HyperGlide Occlusion Balloon System Neurovascular Balloon

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Medtronic HyperGlide™ Occlusion Balloon System
The Medtronic HyperGlide™ Occlusion Balloon System is a compliant neurovascular occlusion balloon catheter designed for temporary vascular occlusion and balloon-assisted aneurysm procedures.

Key Features
Product Name: Medtronic HyperGlide™ Occlusion Balloon System
Manufacturer: Medtronic; FDA-cleared documentation lists the legacy manufacturer as Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Device Type: Occlusion Balloon Catheter
Balloon Style: Oblong compliant balloon
Clinical Positioning: Designed for sidewall aneurysms and reliable occlusions
Usable Length: 150 cm
Proximal Outer Diameter: 2.8F
Distal Outer Diameter: 2.2F
Balloon Diameter Range: 3.0–5.0 mm
Balloon Length Range: 10.0–30.0 mm
Tip Length: 4.0 mm
Guidewire Compatibility: 0.010-inch guidewire
Packaging Note: Packaged with a 0.010-inch X-pedian™ hydrophilic guidewire; sterile, single use

Product Information
Brand: Medtronic HyperGlide™
Product Type: Occlusion Balloon System / Occlusion Balloon Catheter
Vascular Use Area: Peripheral and neuro vasculature
Intended Use: Temporary vascular occlusion
Additional Use Listed by Medtronic: Balloon-assisted embolization of intracranial aneurysms and treatment of vasospasm
Catheter Design: Single-lumen, open-ended catheter
Commercially Cleared Sizes Referenced in FDA 510(k): 4x10, 4x15, 4x20, 4x30 mm
Regulatory Category in FDA Filing: Class II, product code MJN