# K150800: Valved Safety Centesis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Nov 12, 2015 after 231 days
- Product code: GCB (Needle, Catheter)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K870704 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974146: Paracentesis Catheter Device, Allegiance Healthcare Corp. (1998) Summary page 4.

## Indications for use
The Valved Safety Centesis Catheter is indicated for the therapeutic or diagnostic aspiration of fluids from body cavities.

Source page: https://510kreport.com/device/K150800
Methodology: https://510kreport.com/methodology