Device 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.
Z-1517-2013
Product summary
- Firm
- Invatec Llc
- Event
- Event 65289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 177 units
- Official record key
device-enforcement:Z-1517-2013
Official wording
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.
Code information: Serial Numbers/Batches: OPI05931901, OPI05684401, OPI05684501, OPI05684601, OPI05684701, OPI05684801
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.