# Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB

**Predicate Speed & CAPA Advisory Opportunity Score:** 55/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254051 |
| Device | Extroducer Infusion Catheter System |
| Applicant | SmartWise Sweden AB |
| Specialty / panel | Cardiovascular |
| Product code | KRA |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-17 |
| Decision date | 2026-09-11 |
| Review time (days) | 268 |
| Third-party review | No |
| Applicant location | Tullinge, SE |

## Why this score
- A long 268-day review suggests additional-information requests: a firm likely to value regulatory help next time.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254051). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.