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. 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).
Clearance details
- Applicant
- SmartWise Sweden AB
- Product code
- Product 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 allMore 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.