K212165 is an FDA 510(k) clearance for the Reprocessed Carto Vizigo Bi-Directional Guiding Sheath. This device is classified as a Reprocessed Catheter Introducer (Class II - Special Controls, product code PNE).
Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on March 10, 2022, 241 days after receiving the submission on July 12, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340. Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System.
| 510(k) Number | K212165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2021 |
| Decision Date | March 10, 2022 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PNE — Reprocessed Catheter Introducer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |
| Definition | Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System |