FDA-Device2021-09-01Class II
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
Northeast Scientific Inc.
Hazard
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Sold states
US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
Affected count
690 devices
Manufactured in
2142 Thomaston Ave, N/A, Waterbury, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2334-2021Don't want to check this manually?
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