InVera Infusion Device— 510(k) K250794

Name: FDA 510(k) clearance K250794
Creator: U.S. Food and Drug Administration
Published: 2026-03-12

Substantially Equivalent

Invera Medical

FDA 510(k) clearance K250794 for InVera Infusion Device, Substantially Equivalent on 2026-03-12. Applicant: Invera Medical. Device class: 2.

Summary

Invera Medical's InVera Infusion Device is filed under KRA, continuous flush catheters. The record doesn't list sizes or models.

Class II, 21 CFR 870.1210. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Invera Medical filed from Galway, Ireland. Review took 363 calendar days (March 14, 2025 to March 12, 2026).

Clearance details

Applicant: Invera Medical
Product code: Product code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2025-03-14
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRA

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K253509 — TriSalus TriNav Advance Infusion System2026-09-21
K254051 — Extroducer Infusion Catheter System2026-09-11
K261610 — Verge Microcatheter2026-06-11
K260771 — TruSelect 2.6 Microcatheter2026-05-15
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.