FDA-Device2025-10-08Class II
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Northeast Scientific Inc.
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
561 units
Manufactured in
2142 Thomaston Ave, N/A, Waterbury, CT, United States
Products
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0018-2026Don't want to check this manually?
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