# K071167: Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560

- Pathway: 510(k) (Traditional)
- Applicant: Medigroup, Inc.
- Decided: Aug 31, 2007 after 127 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: 1 generation back to K823331 (1983). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950042: Swan Neck Presternal Peritoneal Dialysis Catheter, Accurate Surgical Instruments Co. (1995) Summary page 1.
- K970159: Flex-Neck PD Catheter, Janin Group, Inc. (1997) Summary page 1.
- K823331: PC-204 Tunnelor, Medigroup (1983) Summary page 1.

## Most influential descendants
- K180485: Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender (2018), 0 descendants of its own
- K121383: PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components) (2012), 0 descendants of its own

## Indications for use
If a patient is a suitable adult candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ExxTended TM peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis. Stencils sold with the device, and marketed separately, will be used to assist the physician to locate the optimum primary implantation site and the optimum catheter exit site for the Flex-Neck® ExxTendedTM Catheter.

Source page: https://510kreport.com/device/K071167
Methodology: https://510kreport.com/methodology