K250314 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer. This device is classified as a Reprocessed Catheter Introducer (Class II - Special Controls, product code PNE).
Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on December 19, 2025, 318 days after receiving the submission on February 4, 2025.
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 | K250314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2025 |
| Decision Date | December 19, 2025 |
| Days to Decision | 318 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 |