K161464 is an FDA 510(k) clearance for the Reprocessed Dynamic Tip 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 30, 2016, 127 days after receiving the submission on May 26, 2016.
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 | K161464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2016 |
| Decision Date | September 30, 2016 |
| Days to Decision | 127 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). |