# K060288: Retro Silver and Xpresso Silver Chronic Hemodialysis Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Spire Biomedical, Inc.
- Decided: Sep 1, 2006 after 207 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K013160 (2002). 9 ancestors in all.
No later device cites it as a predicate yet.
3 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013160: Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter, Spire Biomedical, Inc. (2002) Summary page 1.
- K021212: 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips, Spire Biomedical, Inc. (2002) Summary page 1.
- K022000: Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes), Spire Biomedical, Inc. (2002) Summary page 1.
- K041559: 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model #RS50SH55,RS50NH55,RE50SH55 & RE50NH55, Spire Biomedical, Inc. (2004) Summary page 1.
- K961433: Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone Screws, Electro-Biology, Inc. (1996) Summary page 1.
- K993933: 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume Infusions, Pro, Arrow Intl., Inc. (2000) Summary page 1.

## Indications for use
Spire Biomedical Inc.'s RetrO SilverTM and XpressO SilverTM Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips are designed for chronic hemodialysis and apheresis. They are radiopaque silicone catheters designed for percutaneous insertion or insertion via a cutdown. Catheters longer than 40cm are intended for femoral vein insertion. The silver coating on the catheter may reduce bacterial surface colonization for up to two months. This performance was supported by literature citing clinical testing.

Source page: https://510kreport.com/device/K060288
Methodology: https://510kreport.com/methodology