K220171 is an FDA 510(k) clearance for the NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter. This device is classified as a Reprocessed Atherectomy Catheter (Class II - Special Controls, product code QTF).
Submitted by Northeast Scientific, Inc. (Waterbury, US). The FDA issued a Cleared decision on July 1, 2022, 161 days after receiving the submission on January 21, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 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.
| 510(k) Number | K220171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2022 |
| Decision Date | July 01, 2022 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QTF - Reprocessed Atherectomy Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4875 |
| Definition | Reprocessed Atherectomy Device For Peripheral Vasculature. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission |