K201806 is an FDA 510(k) clearance for the Reprocessed PentaRay Nav eco High-Density Mapping Catheter. This device is classified as a Catheter, Intracardiac Mapping, High-density Array (Class II - Special Controls, product code MTD).
Submitted by Sterilmed Inc. (Johnson and Johnson) (Plymouth, US). The FDA issued a Cleared decision on June 23, 2021, 357 days after receiving the submission on July 1, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K201806 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2020 |
| Decision Date | June 23, 2021 |
| Days to Decision | 357 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MTD - Catheter, Intracardiac Mapping, High-density Array |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |