The following data is part of a premarket notification filed by Northeast Scientific, Inc. with the FDA for Nes Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter.
| Device ID | K220171 |
| 510k Number | K220171 |
| Device Name: | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter |
| Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
| Applicant | Northeast Scientific, Inc. 2142 Thomaston Ave. Waterbury, CT 06704 |
| Contact | Matthew Farley |
| Correspondent | Matthew Farley Northeast Scientific, Inc. 2142 Thomaston Ave. Waterbury, CT 06704 |
| Product Code | QTF |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-21 |
| Decision Date | 2022-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| NRP368 | K220171 | 000 |
| B227NRP3680 | K220171 | 000 |