# K012562: Medcomp 14.5F Double Lumen Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Feb 8, 2002 after 184 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: 1 generation back to K981994 (1998). 1 ancestor in all.
38 later devices descend from it; 5 cite it directly.
3 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981994: Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter, C.R. Bard, Inc. (1998) Summary page 1.

## Most influential descendants
- K020465: Medcomp Ash Split-Cath II (2002), 29 descendants of its own
- K030502: 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55 (2003), 13 descendants of its own
- K030020: Hemosplit Long-Term Hemodialysis Catheter (2003), 12 descendants of its own
- K022678: Medcomp SC4 (2003), 11 descendants of its own
- K033294: Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with Microintroducer (2003), 10 descendants of its own

## Indications for use
THE MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.

Source page: https://510kreport.com/device/K012562
Methodology: https://510kreport.com/methodology