K211276 is an FDA 510(k) clearance for the Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters. This device is classified as a Catheter, Recording, Electrode, Reprocessed (Class II - Special Controls, product code NLH).
Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on September 15, 2021, 141 days after receiving the submission on April 27, 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 | K211276 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2021 |
| Decision Date | September 15, 2021 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NLH — Catheter, Recording, Electrode, 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). |