K190785 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, Reprocessed (Class II - Special Controls, product code NLG).
Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on June 25, 2019, 90 days after receiving the submission on March 27, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf)..
| 510(k) Number | K190785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2019 |
| Decision Date | June 25, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NLG — Catheter, Intracardiac Mapping, High-density, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |
| Definition | Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf). |