# K143583: Cathivex ¿GV filter units

- Pathway: 510(k) (Traditional)
- Applicant: Merck Millipore, Ltd.
- Decided: Aug 11, 2015 after 236 days
- Product code: FPB (Filter, Infusion Line)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993379 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993379: Pall Supor Aef Filter, Pall Corp. (1999) Summary page 5.

## Indications for use
Cathivex®-GV filter units are in-line 0.22µm, sterilizing-grade filters for use with intravenously administered aqueous solutions. The filters remove particulates, microbial contamination, and air bubbles in applications where venting and low protein binding membranes are required or desired.

Source page: https://510kreport.com/device/K143583
Methodology: https://510kreport.com/methodology