# K171646: ACISTCVi® Contrast Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Acist Medical Systems, Inc.
- Decided: Feb 16, 2018 after 256 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: 4 generations back to K822536 (1982). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991103: Modification to Acist CL 100H, Acist Medical Systems (2000) Summary page 4.
- K984231: Angiographic Contrast Management System, Model Part a and Part B, Invasatec (2000) Summary page 4.

## Most influential descendants
- K191060: ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit (2019), 2 descendants of its own
- K203004: ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (2020), 1 descendant of its own
- K252653: ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable (2026), 0 descendants of its own
- 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) (2026), 0 descendants of its own

## Indications for use
The ACIST|CVi® Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The ACIST|CVi® Contrast Delivery System 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 Syringe Kit must be discarded after six (6) patient procedures. The Manifold Kit and AngioTouch Hand Controller Kit must be discarded after each patient procedure. The ACIST|CVi® Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

Source page: https://510kreport.com/device/K171646
Methodology: https://510kreport.com/methodology