Extroducer Infusion Catheter System— 510(k) K254051
Substantially EquivalentSmartWise Sweden AB
FDA 510(k) clearance K254051 for Extroducer Infusion Catheter System, Substantially Equivalent on 2026-09-11. Applicant: SmartWise Sweden AB. Device class: 2.
Summary
The Extroducer Infusion Catheter System is filed under KRA, continuous-flush catheters. These are intravascular catheters that keep fluid moving through the lumen, for infusion or to keep the line patent. The record doesn't say which vessels it's meant for.
Class II, 21 CFR 870.1210. The Cardiovascular panel reviewed it as a Traditional 510(k).
SmartWise Sweden filed from Tullinge, Sweden. The clock ran 268 days (December 17, 2025 to September 11, 2026). FDA's 90-day goal only counts the agency's own review time, so on a clock this long most of the gap is usually the applicant answering questions.
Clearance details
- Applicant
- SmartWise Sweden AB
- Product code
- Code KRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tullinge, SE
Recent devices under product code KRA
view all- K261610 — Verge Microcatheter
- K260771 — TruSelect 2.6 Microcatheter
- K250794 — InVera Infusion Device
- K243534 — Micro Catheter
- K231821 — XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
More clearances from SmartWise Sweden AB
view allAdverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.