# K012983: Acist 4 French Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Acist Medical Systems, Inc.
- Decided: Mar 13, 2002 after 189 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis Infinity Sones Angiographic Catheter: named in the summary without a submission number

## Most influential descendants
- K021015: Acist Plus 4 Angiographic Catheter (2002), 0 descendants of its own

## Indications for use
The Acist 4 French Angiographic Catheter is intended for use to deliver radiopaque contrast medium to selected sites in the vasculature.

Source page: https://510kreport.com/device/K012983
Methodology: https://510kreport.com/methodology