# K111651: Split Cath Iii

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Dec 8, 2011 after 178 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 35 ancestors in all.
No later device cites it as a predicate yet.
2 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040318: Medcomp Split-Cath II, Medcomp (2005) Summary page 1.
- K020465: Medcomp Ash Split-Cath II, Medcomp (2002) Summary page 1.
- K091953: Pro-Picc, Medcomp (2009) Summary page 1.
- K051280: Medcomp Split Cath II, Medcomp (2005) Summary page 1.
- K981125: Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6, Medical Components, Inc. (1999) Summary page 1.

## Recalls of this device
- Feb 5, 2015 · Class II · Z-1351-2015: Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product ship

## Indications for use
The Medcomp® Split Cath® III is indicated for use in attaining long term vascular access for Hemodialysis and Apheresis in the adult patient. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and inferior vena cava as required. Catheters greater than 40cm are intended for femoral vein or inferior vena cava insertion. Translumbar insertion via inferior vena cava is indicated when all other access sites are identified as non-viable. The Medcomp® Split Cath® III 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/K111651
Methodology: https://510kreport.com/methodology