Submission Details
| 510(k) Number | K250314 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
Dec 2025
Decision
318d
Days
Class 2
Risk
About This 510(k) Submission
K250314 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer, 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 review panel. Regulated under 21 CFR 870.1340.
Device Classification
| 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 |
Manufacturer
Surgical Instrument Service and Savings, Inc.
Redmond, OR · US
Stephanie Boyle Mays
23 submissions
23 cleared
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