510(k) K220171 ยท QTF Reprocessed Atherectomy Catheter
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
| Applicant | Northeast Scientific, Inc., Waterbury CT, US |
| Decision | Substantially Equivalent, Jul 1, 2022 |
| Received | Jan 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220171
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2025 | Northeast Scientific Inc. 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 Open, Classified |
QTF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.