# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Acist Medical Systems, Inc.
- Decided: May 13, 2026 after 266 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K822536 (1982). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203004: ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System, Acist Medical Systems, Inc. (2020) Summary page 5.

## Indications for use
The VeraPro Syringe is intended for use with the ACIST Pro Diagnostic System for controlled administration of radiopaque contrast media and saline to human subjects undergoing angiographic procedures. The VeraPro S100 is for multi-use and must be discarded after five (5) patient procedures. In multi-use mode, the VeraPro S100 is specifically indicated for use in angiographic procedures for the delivery of ISOVUE® (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of ten (10) hours. The VeraPro Syringe is intended for use with the ACIST Pro Diagnostic System for controlled administration of radiopaque contrast media and saline to human subjects undergoing angiographic procedures. The VeraPro S100 LV1 is for single-use and must be discarded after each patient procedure. The VeraPro Auto-Manifold and Transducer is intended for use with the ACIST Pro Diagnostic System for controlled administration of radiopaque contrast media and saline to human subjects undergoing angiographic procedures. The VeraPro AMT is for single-use and must be discarded after each patient procedure. The VeraPro AngioTouch Hand Controller Kit is intended for use with the ACIST Pro Diagnostic System (ACIST Pro System) for controlled administration of radiopaque contrast media and saline to human subjects undergoing angiographic procedures. The VeraPro AngioTouch HiFi 165 and FLX 165 Hand Controller Kits are for single-use and must be discarded after each patient procedure.

Source page: https://510kreport.com/device/K252638
Methodology: https://510kreport.com/methodology