# K191232: AccuCath Ace Intravascular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 18, 2019 after 133 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K854773 (1986). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162894: AccuCath Intravascular Catheter, C.R. Bard, Inc. (2016) Summary page 5.

## Indications for use
The AccuCath Ace™ Intravascular Catheter is indicated for vascular access, including both the external and internal jugular veins, to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath Ace™ IV Catheter is suitable for use with power injectors.

Source page: https://510kreport.com/device/K191232
Methodology: https://510kreport.com/methodology