Cleared Traditional

InVera Infusion Device

K250794 · Invera Medical · Cardiovascular
Mar 2026
Decision
363d
Days
Class 2
Risk

About This 510(k) Submission

K250794 is an FDA 510(k) clearance for the InVera Infusion Device, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Invera Medical (Galway, IE). The FDA issued a Cleared decision on March 12, 2026, 363 days after receiving the submission on March 14, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K250794 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2025
Decision Date March 12, 2026
Days to Decision 363 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRA — Catheter, Continuous Flush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1210

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