# K113354: Veta Peritoneal Dialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: Mar 13, 2012 after 120 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
Longest line of descent: 3 generations back to K010642 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K812607: Tenckhoff Peritoneal Catheters, Quinton, Inc. (1981) Summary page 1.
- K093796: Asept Peritoneal Drainage System, Pfm Medical, Inc. (2010) Summary page 1.
- K051711: Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits, Denver Biomedical, Inc. (2005) Summary page 1.

## Recalls of this device
- Oct 20, 2014 · Class II · Z-0568-2015: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

## Indications for use
The Veta Peritoneal Dialysis Catheter is indicated for acute and chronic access to the peritoneal cavity. The Veta Peritoneal Dialysis Catheters will be used to drain and infuse fluid during peritoneal dialysis procedures.

Source page: https://510kreport.com/device/K113354
Methodology: https://510kreport.com/methodology