VeraPro S100 Multi-Use Syringe (018808) +4 more— 510(k) K252638
Substantially EquivalentAcist Medical Systems, Inc.
FDA 510(k) clearance K252638 for VeraPro S100 Multi-Use Syringe (018808) +4 more, Substantially Equivalent on 2026-05-13. Applicant: Acist Medical Systems, Inc.. Device class: 2.
Summary
Acist Medical Systems' record covers five VeraPro items: the S100 Multi-Use Syringe (018808), the S100 LV1 Low Viscosity Single-Use Syringe (018811), the AMT Auto-Manifold and Transducer (018814), and the AngioTouch FLX165 (018806) and HiFi165 (018804) Hand Controller Kits. The product code is DXT, angiographic injectors and syringes.
Class II, 21 CFR 870.1650. The General Hospital review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Acist filed from Eden Prairie, Minnesota. Review took 266 calendar days (August 20, 2025 to May 13, 2026).
Clearance details
- Device name as filed
- 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.
- Product code
- Product code DXT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code DXT
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- K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
- K251788 — Extension tube
More clearances from Acist Medical Systems, Inc.
view all- K262115 — VueJect® Ultrasound Enhancing Agent Delivery System
- K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
- K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
- K193183 — ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
- K190473 — ACIST RXi System and Navvus II Catheter
Adverse events under product code DXT
product code DXT- Death
- 39
- Injury
- 242
- Malfunction
- 463
- Other
- 3
- Total
- 747
Source: openFDA MAUDE database, through . 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.