K212776 is an FDA 510(k) clearance for the Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. 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 December 20, 2021, 110 days after receiving the submission on September 1, 2021.
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 | K212776 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2021 |
| Decision Date | December 20, 2021 |
| Days to Decision | 110 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). |