Device product
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.
Z-1143-2013
Product summary
- Firm
- Elana, Inc.
- Event
- Event 64538
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 devices
- Official record key
device-enforcement:Z-1143-2013
Official wording
Reason: Distribution of an unapproved device into interstate commerce.
Code information: Model 280, S/N 776, S/N 706, S/N 758
Distribution pattern: Distributed in the states of Pennsylvania, Texas, and New York.
Derived failure modes
-
Unknown
Distribution of an unapproved device into interstate commerce.