K230376 is an FDA 510(k) clearance for the Reprocessed Agilis NxT Steerable Introducer. 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 August 7, 2023, 175 days after receiving the submission on February 13, 2023.
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 | K230376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2023 |
| Decision Date | August 07, 2023 |
| Days to Decision | 175 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 |