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VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)

by ACIST Medical Systems, Inc.

510(k) K252638

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) K252638↗

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
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK252638 Date13 May 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
DXT
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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 VeraPro product line includes angiographic injectors and syringes designed for cardiovascular imaging procedures. The VeraPro S100 Multi-Use Syringe (018808) and VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811) are syringe-based injectors used to deliver contrast agents during angiographic studies. The VeraPro AMT Auto-Manifold and Transducer (018814) integrates automated manifold and transducer technology for precise fluid management, while the VeraPro AngioTouch FLX165 and HiFi165 Hand Controller Kits (018806, 018804) provide ergonomic hand controllers for operator control during imaging.

These devices are intended for use in clinical settings such as catheterization labs and angiography suites. The VeraPro S100 Multi-Use Syringe is reusable, while the LV1 variant is single-use, ensuring sterility and compliance with procedural protocols. All components are designed for compatibility with MRI environments, adhering to strict safety standards. The kits are supplied as modular systems, requiring proper storage and handling as per manufacturer guidelines, and are authorized under FDA 510(k) clearance and MDR compliance.

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