# K971925: Medcomp Bio-Flex CS Catheter (CS100)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Feb 23, 1998 after 276 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
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
3 of 13 devices 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.

## Most influential descendants
- K022678: Medcomp SC4 (2003), 11 descendants of its own
- K040318: Medcomp Split-Cath II (2005), 9 descendants of its own
- K070572: Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM (2007), 7 descendants of its own
- K080400: Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit (2008), 6 descendants of its own
- K101843: Duramax Chronic Hemodialysis Catheter and Procedure Kit (2010), 2 descendants of its own

## Recalls of this device
- Sep 2, 2009 · Not classified · Z-0161-2010: mislabeled as right are actually left

## Indications for use
The Medcomp Bio-Flex™ CS Catheter with Adjustable Cuff is designed for fong term hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Although this catheter may be inserted into the subclavian vein, the internal jugular is the preferred site.

Source page: https://510kreport.com/device/K971925
Methodology: https://510kreport.com/methodology