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Devices
Device Recall Elana Catheter Sizer 2.0
Model / Serial
Model 280, S/N 776, S/N 706, S/N 758
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the states of Pennsylvania, Texas, and New York.
Product Description
Elana Catheter Sizer 2.0*** || The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Manufacturer
Elana, Inc.
1 Event
Recall of Device Recall Elana Catheter Sizer 2.0
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Manufacturer
Elana, Inc.
Manufacturer Address
Elana, Inc., 10480 Little Patuxent Pkwy, Suite 400, Columbia MD 21044-3568
Source
USFDA
Language
English
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