Recall Z-1143-2013— Elana, Inc.
Class II · Terminated
Class II FDA medical device recall by Elana, Inc., initiated 2013-02-14, terminated 2013-05-09. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Distribution of an unapproved device into interstate commerce..
- Recalling firm
- Elana, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-14
- Terminated
- 2013-05-09
- Firm location
- Columbia, MD, United States
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.
Reason for recall
Distribution of an unapproved device into interstate commerce.
Data sourced from openFDA. This site is unofficial and independent of the FDA.