# K973561: Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM, Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 1M

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: May 11, 1998 after 234 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
1 of 7 devices in its family (counting itself) has 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.

## Most influential descendants
- K033570: Medcomp T-3 (2004), 4 descendants of its own
- K123292: T3 (2013), 2 descendants of its own
- K183219: Trio-CT Triple Lumen Catheter (2019), 1 descendant of its own
- K232945: Trio-CT­® Triple Lumen Catheter w/ Curved Extensions (2023), 0 descendants of its own
- K181175: 12F Tri-Flow Triple Lumen Catheter (2018), 0 descendants of its own

## Indications for use
The Medcomp Tri-Flow™ Triple Lumen Catheter is designed for acute central vein catheterization, TPN, fluid administration, drug infusion, and continuous therapies. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian or femoral vein, the internal jugular is the preferred site.

Source page: https://510kreport.com/device/K973561
Methodology: https://510kreport.com/methodology