Device product
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
Z-2334-2021
Product summary
- Event
- Event 88345
- Status
- Terminated
- Classification
- Class II
- Quantity
- 690 devices
- Official record key
device-enforcement:Z-2334-2021
Official wording
Reason: 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Code information: Lots L0017886 through L0020553
Distribution pattern: US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
Derived failure modes
-
Unknown
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.