# K032962: AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial Surface

- Pathway: 510(k) (Special)
- Applicant: Arrow Intl., Inc.
- Decided: Oct 29, 2003 after 36 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: 3 generations back to K895417 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
6 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011761: Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis Valve/Side Port, Arrow Intl., Inc. (2001)
- K981909: Baxter Hemostasis Valve Introducers, Baxter Edwards (1998) Summary page 1.

## Indications for use
The Arrow Central Venous Access Product permits venous access and catheter introduction to the central circulation. The ARROWg+ard Blue@antimicrobial surface is intended to help provide protection against access device-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.

Source page: https://510kreport.com/device/K032962
Methodology: https://510kreport.com/methodology