Recall Z-1517-2013— Invatec Llc
Class II · Terminated
Class II FDA medical device recall by Invatec Llc, initiated 2009-03-04, terminated 2013-06-10. It names 2 FDA 510(k) clearances: K051917, K050276. Product: 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.. Reason: Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified..
- Recalling firm
- Invatec Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2009-03-04
- Terminated
- 2013-06-10
- Firm location
- Bethlehem, PA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.
Data sourced from openFDA. This site is unofficial and independent of the FDA.