Reprocessed Atherectomy Catheter
FDA product code QTF · Class II (moderate risk) · 21 CFR 870.4875 · Cardiovascular
Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission
1510(k) clearances
0PMA approvals
8recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterQTF · Traditional | Northeast Scientific, Inc. | 07/01/2022SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0025-2026 Class II | NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Northeast Scientific Inc. | 08/29/2025Open, Classified |
| Z-0024-2026 Class II | NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Northeast Scientific Inc. | 08/29/2025Open, Classified |
| Z-0023-2026 Class II | NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Northeast Scientific Inc. | 08/29/2025Open, Classified |
| Z-0022-2026 Class II | NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Northeast Scientific Inc. | 08/29/2025Open, Classified |
| Z-0021-2026 Class II | NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Northeast Scientific Inc. | 08/29/2025Open, Classified |
| Z-0020-2026 Class II | NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Northeast Scientific Inc. | 08/29/2025Open, Classified |
| Z-0019-2026 Class II | NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Northeast Scientific Inc. | 08/29/2025Open, Classified |
| Z-0018-2026 Class II | NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number:…Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Northeast Scientific Inc. | 08/29/2025Open, Classified |