# K961392: Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II

- Pathway: 510(k) (Traditional)
- Applicant: Sil-Med Corp.
- Decided: Jul 18, 1997 after 463 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 K850247 (1985). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850247: Peritoneal Dialysis Coil Catheter, Sil-Med Corp. (1985) Summary page 1.
- K942709: Mediastinal Silicone Drains, Sil-Med Corp. (1996) Summary page 1.
- K900263: Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (1990) Summary page 1.

## Most influential descendants
- K012193: Amc Antimicrobial Pin/Wire Sleeve (2002), 2 descendants of its own
- K022688: Versabond AB Bone Cement (2004), 0 descendants of its own
- K022676: Orthoguard AB Antimicrobial Sleeve (2002), 0 descendants of its own

## Indications for use
Peritoneal Dialysis Catheter with Spi-Argent™ill surface treatment, for the transport of dialysate solution to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis)

Source page: https://510kreport.com/device/K961392
Methodology: https://510kreport.com/methodology