K221390 is an FDA 510(k) clearance for the BNLE Access Guidewire. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Biomerics Nle (Brooklyn Park, US). The FDA issued a Cleared decision on April 28, 2023, 350 days after receiving the submission on May 13, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K221390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2022 |
| Decision Date | April 28, 2023 |
| Days to Decision | 350 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX - Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |