K211662 is an FDA 510(k) clearance for the Reprocessed IntellaMap Orion High Resolution 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 November 18, 2021, 170 days after receiving the submission on June 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 | K211662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2021 |
| Decision Date | November 18, 2021 |
| Days to Decision | 170 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). |