K191880 is an FDA 510(k) clearance for the Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter. This device is classified as a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II - Special Controls, product code DRF).
Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on December 11, 2019, 149 days after receiving the submission on July 15, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K191880 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2019 |
| Decision Date | December 11, 2019 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |