FDA-Device2013-06-12Class II
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Invatec Llc
Hazard
Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.
Sold states
Nationwide Distribution
Affected count
177 units
Manufactured in
3101 Emrick Blvd, N/A, Bethlehem, PA, United States
Products
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1517-2013Don't want to check this manually?
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