# K042672: 14F Dual Floating Dialysis Catheter/Tray

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Med Supplies, Inc.
- Decided: Mar 23, 2005 after 175 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CMS Dual Floating Dialvsis Catheters are indicaled for use in attaining vascular access sites for llemodialNs is and Aphercsis treatments. Ithe device is attended to be inserted into the internal jug. juar vein ofan aduh atioi it. Catheter greater than 40cm1 are intended tbr fnmoral xeia insertion Ahernale insertion site is the sUbclav ian vein as qui red, Fhis cadheter is indicatd I! dLor ur/I I nIot to exceed I 2 ml/onths

Source page: https://510kreport.com/device/K042672
Methodology: https://510kreport.com/methodology