Extroducer Infusion Catheter System
FDA 510(k) K254051 · SmartWise Sweden AB
510(k) numberK254051
Submission
- Device name
- Extroducer Infusion Catheter System
- Applicant
- SmartWise Sweden AB
Tullinge, SE - Received
- December 17, 2025
- Decision date
- September 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRA – Catheter, Continuous Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1210
- Specialty
- Cardiovascular
Other 510(k)s with product code KRA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261610 | Verge MicrocatheterKRA · Special | Instylla, Inc. | 06/11/2026SE |
| K260771 | TruSelect 2.6 MicrocatheterKRA · Special | Boston Scientific Corporation | 05/15/2026SE |
| K250794 | InVera Infusion DeviceKRA · Traditional | Invera Medical | 03/12/2026SE |
| K243534 | Micro CatheterKRA · Traditional | Suzhou Zenith Vascular SciTech Limited | 07/30/2025SE |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…KRA · Traditional | Transit Scientific, LLC | 11/29/2023SE |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmKRA · Traditional | Ablative Solutions, Inc. | 07/05/2023SE |
| K231148 | ScleroSafe 150 mm, ScleroSafe 350 mmKRA · Traditional | Vvt Medical , Ltd. | 06/20/2023SE |
| K230957 | TriSalus TriNav® LV Infusion SystemKRA · Traditional | Trisalus Life Sciences | 05/02/2023SE |
| K223139 | Wallaby 017 Micro CatheterKRA · Traditional | Wallaby Medical | 04/25/2023SE |
| K223176 | Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus…KRA · Special | Argon Medical Devices, Inc. | 04/10/2023SE |
More from Argon Medical Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213442 | Extroducer Infusion Catheter SystemKRA · Traditional | 06/10/2022SE |
Questions and answers
When was Extroducer Infusion Catheter System cleared by the FDA?
Extroducer Infusion Catheter System (K254051) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 268 days after the submission was received.
What is the product code of K254051?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.