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Invatec

1 recall •
🏥 Medical Devices
• Categories: Surgical Instruments

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.

Class I - Dangerous

Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.

Mar 4, 2009 Surgical Instruments Nationwide View Details →