# K070730: Flex-Neck Arc Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medigroup, Inc.
- Decided: Jul 3, 2007 after 110 days
- Product code: FJS (Catheter, Peritoneal, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- 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 K970159 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862046: Swan-Neck Peritoneal Dialysis Catheters, Accurate Surgical Instruments Co. (1986) Summary page 1.
- K970159: Flex-Neck PD Catheter, Janin Group, Inc. (1997) Summary page 1.
- K031351: Flex-Neck PD Catheter, Infant, Medigroup, Inc. (2003) Summary page 1.

## Indications for use
If a patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ARC TM peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis.

Source page: https://510kreport.com/device/K070730
Methodology: https://510kreport.com/methodology