Reprocessed Atherectomy Catheter
Cardiovascular · 21 CFR 870.4875
Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
8 recall events for this product code
- Northeast Scientific Inc.Open, ClassifiedOct 2, 2025
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0018-2026 · View FDA record ↗ - Northeast Scientific Inc.Open, ClassifiedOct 2, 2025
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0019-2026 · View FDA record ↗ - Northeast Scientific Inc.Open, ClassifiedOct 2, 2025
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0020-2026 · View FDA record ↗ - Northeast Scientific Inc.Open, ClassifiedOct 2, 2025
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0021-2026 · View FDA record ↗ - Northeast Scientific Inc.Open, ClassifiedOct 2, 2025
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0022-2026 · View FDA record ↗ - Northeast Scientific Inc.Open, ClassifiedOct 2, 2025
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0023-2026 · View FDA record ↗ - Northeast Scientific Inc.Open, ClassifiedOct 2, 2025
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0024-2026 · View FDA record ↗ - Northeast Scientific Inc.Open, ClassifiedOct 2, 2025
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0025-2026 · View FDA record ↗
Registered firms
1 firms currently registered for this product code
510(k) clearances
1 clearances for this product code