# K133004: Vented Millex -GV, Cathivex -GV

- Pathway: 510(k) (Traditional)
- Applicant: Merck Millipore, Ltd.
- Decided: Mar 27, 2014 after 183 days
- Product code: BSN (Filter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5130
- 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 K023892 (2003). 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)
- K023892: Millex VV, GV, and HV Syringe Filter Units, Millipore Corp. (2003) Summary page 2.

## Indications for use
Vented Millex®-GV filter units are syringe filters for sterilization of low volume aqueous solutions for direct patient injection, filtration of laboratory solutions, and filtration of clinical solutions where venting and low protein binding membrane are required or desired. Cathivex®-V filter units are in-line gravity fed filters for the sterilization of aqueous solutions for administration via the neuraxial route, filtration of laboratory solutions, and filtration of clinical solutions where venting and low protein binding membrane are required or desired.

Source page: https://510kreport.com/device/K133004
Methodology: https://510kreport.com/methodology