Devices

TheraSphere(R) YTTRIUM90 GLASS MICROSPHERE

Model / Serial
Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)
Product Classification
Radiology Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution - US to CA, FL, IL, WI, IN, OR, PA, MA, NY, KY, TX, MI, MD, NV, WA, OH, MN, and Internationally to Germany, Turkey, Hong Kong, Italy, Portugal
Product Description
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION || TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
Manufacturer
Biocompatibles U.K., Ltd.
1 Event
- Recall of TheraSphere(R) YTTRIUM90 GLASS MICROSPHERE

Manufacturer

Biocompatibles U.K., Ltd.

Manufacturer Address
Biocompatibles U.K., Ltd., Bortoli House, Weydon Lane; Old Farnham Lane, Farnham United Kingdom
Manufacturer Parent Company (2017)
Btg Plc
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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