K200324 is an FDA 510(k) clearance for the NHancer Rx. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Imds Operations B.V. (Roden, NL). The FDA issued a Cleared decision on August 6, 2020, 178 days after receiving the submission on February 10, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K200324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2020 |
| Decision Date | August 06, 2020 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |