# K970159: Flex-Neck PD Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Janin Group, Inc.
- Decided: Sep 5, 1997 after 232 days
- Product code: FJS (Catheter, Peritoneal, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 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)
- None. The FDA summary names its predicate without a number.
- (no number) Swan Neck™: named in the summary without a submission number
- (no number) Coiled Tenckhoff: named in the summary without a submission number

## Most influential descendants
- K071167: Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560 (2007), 2 descendants of its own
- K031351: Flex-Neck PD Catheter, Infant (2003), 1 descendant of its own
- 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
- K070730: Flex-Neck Arc Catheter (2007), 0 descendants of its own

## Recalls of this device
- Dec 20, 2017 · Class II · Z-2823-2018: Mix-up between adult and pediatrics PD catheter.

## Indications for use
If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck™ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Flex-Neck™ PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC® System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

Source page: https://510kreport.com/device/K970159
Methodology: https://510kreport.com/methodology