Extroducer Infusion Catheter System— 510(k) K213442

Name: FDA 510(k) clearance K213442
Creator: U.S. Food and Drug Administration
Published: 2022-06-10

Substantially Equivalent

SmartWise Sweden AB

FDA 510(k) clearance K213442 for Extroducer Infusion Catheter System, Substantially Equivalent on 2022-06-10. Applicant: SmartWise Sweden AB. Device class: 2.

Clearance details

Applicant: SmartWise Sweden AB
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2021-10-25
Decision date: 2022-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tullinge, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRA

view all

K254051 — Extroducer Infusion Catheter System2026-09-11
K261610 — Verge Microcatheter2026-06-11
K260771 — TruSelect 2.6 Microcatheter2026-05-15
K250794 — InVera Infusion Device2026-03-12
K243534 — Micro Catheter2025-07-30

Adverse 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, 2020-01-01 through 2026-04-23. 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.