FDA-Device2025-10-08Class II
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.
Hazard
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Sold states
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Affected count
173 units
Manufactured in
2142 Thomaston Ave, N/A, Waterbury, CT, United States
Products
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0019-2026Want us to check the next one for you?
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