# K991042: Ash Advantage Peritoneal Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Janin Group, Inc.
- Decided: Jun 25, 1999 after 88 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Peritoneal Dialysis Catheter: named in the summary without a submission number
- (no number) Swan Neck™ Peritoneal Dialysis Catheter: named in the summary without a submission number
- (no number) Tenckhoff Catheter: named in the summary without a submission number
- (no number) Flex-Neck™ Catheter: named in the summary without a submission number

## Indications for use
The Ash Advantage™ Peritoneal Catheter is intended to provide access for passage of dialysate during chronic peritoneal dialysis (PD) such as Continuous Ambulatory Peritoneal Dialysis (CAPD). If the patient is a suitable candidate for (PD) therapy, the Ash Advantage™ Peritoneal Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Ash Advantage™ Peritoneal 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/K991042
Methodology: https://510kreport.com/methodology