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InVera Infusion Device

by InVera Medical

510(k) K250794Ref IMC006

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250794↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number539154739001EW Basic UDI-DI 05391547390002UDI-DIDate26 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250794 Date12 Mar 2026ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / Reference
IMC006
Primary DI / UDI-DI
05391547390002
Basic UDI-DI
539154739001EW
510(k) Number
FDA Product Code
KRA
EMDN Code
C0199 Arterio-venous devices - other
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 870.1210
EU market of registration
Ireland
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The InVera Infusion Device is a Catheter, Continuous Flush, designed for maintaining patency in vascular access lines by delivering a continuous flow of flush solution. It is classified as a Class II medical device and is intended for use in cardiovascular applications, ensuring uninterrupted fluid pathways in clinical settings.

This device is supplied as a single-use, sterile product and is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR). It is intended for use in hospital or clinical environments, with multiple catheter sizes and reference codes available for compatibility with various vascular access systems. The device adheres to MRI safety standards where applicable and is authorised for distribution under the product code KRA.

Properties

  • Sterile
  • CMR Substance
  • Administering Medicine

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No