Devices

Device Recall Elana Surgical KitHUD

Model / Serial
Manufacturers Product Number, 801-H Lot/Serial Number, 160301
Product Classification
Neurological Devices
Device Class
HDE
Implanted device?
No
Distribution
Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.
Product Description
Elana Surgical KitHUD || The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity
Manufacturer
Elana, Inc.
1 Event
- Recall of Device Recall Elana Surgical KitHUD

Manufacturer

Elana, Inc.

Manufacturer Address
Elana, Inc., 10480 Little Patuxent Pkwy Ste 400, Columbia MD 21044-3576
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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