# K233106: AccuCath Ace™ Intravascular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc. (C.R. Bard, Inc.)
- Decided: Apr 19, 2024 after 205 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 Acem Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used for adult and pediatric patients, including those patients with difficult intravascular access who may have small, fragile, and/or non-palpable vessels, with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath Acem IV Catheter is suitable for use with power injectors.

Source page: https://510kreport.com/device/K233106
Methodology: https://510kreport.com/methodology