K252638

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)

510(k) number: K252638
Device name: 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)
Applicant: Acist Medical Systems, Inc. MN · US
Product code: DXT — Injector And Syringe, Angiographic
Decision date: 2026-05-13
Date received: 2025-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K252638.pdf

Official FDA record: K252638

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.