# K070451: Able Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Nanhai Bai HE Medical Technology Co., Ltd.
- Decided: Jul 31, 2007 after 166 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: 2 generations back to K900263 (1990). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021130: Specath Central Venous Catheter Kits, Special Medical Co., Ltd. (2003) Summary page 2.
- K024007: Sunder Central Venous Catheter Kit, Models SD-3L55F30J and SD-3L70F30J, Sunder Biomedical Tech. Co., Ltd. (2003) Summary page 2.

## Most influential descendants
- K193158: ACENT™ Central Venous Catheter (2020), 0 descendants of its own

## Indications for use
The Central Venous Catheters including: 14 G. 16 G. 18 C, and 20 G in single-lumen catheters; 4 F.5 F, 7 F and 8 F in double-lumen catheter; 5.5 F and 7 F in triple-lumen catheter; are intended for vascular access infusion and withdrawal of blood, blood products, and fluids, plasma pheresis, hyperalimentation, central venous blood sampling and continuous and intermittent drag infusion.

Source page: https://510kreport.com/device/K070451
Methodology: https://510kreport.com/methodology