# K113487: Hemo-Cath 10F, Hemo-Cath 12.5F

- Pathway: 510(k) (Special)
- Applicant: Medical Components, Inc.
- Decided: Mar 9, 2012 after 107 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: 9 generations back to K001901 (2000). 29 ancestors in all.
3 later devices descend from it; 2 cite it directly.
2 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893439: Hemo-Cath Silicone Double Lumen Cath SL28C & SL40C, Medical Components, Inc. (1989) Summary page 1.
- K091953: Pro-Picc, Medcomp (2009) Summary page 1.
- K981125: Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6, Medical Components, Inc. (1999) Summary page 1.
- K030270: 3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone Vascu-Picc, 5F X 60 CM Single Lumen Silicon, Medcomp (2003) Summary page 1.
- K010306: Medcomp Excell Split Tip Catheter, Medcomp (2001)

## Most influential descendants
- K130851: Cascade Hemodialysis/Apheresis Catheter (2014), 1 descendant of its own
- K241581: Hemodialysis Catheter (2025), 0 descendants of its own
- K121383: PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components) (2012), 0 descendants of its own

## Indications for use
Medcomp's Hemo-Cath® silicone double lumen catheter can be utilitized for long term implantation as well as temporary access for hemddialysis, hemoperfusion, or apheresis therapy. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternative insertion sites include subclavian vein as required.

Source page: https://510kreport.com/device/K113487
Methodology: https://510kreport.com/methodology