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Vented Millex -gv, Cathivex -gv

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K133004

by Merck Millipore Ltd

Identifiers

510(k) Number
K133004 FDA 510(k)
FDA Product Code
BSN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5130 FDA 510(k)
Regulation Number
868.5130 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vented Millex-GV and Cathivex-GV are sterile, vented conduction filters designed for anesthetic gas scavenging systems. These devices are classified as Class II medical devices under FDA regulations and are intended to remove volatile anesthetic agents from breathing circuits, ensuring patient safety by preventing gas accumulation in operating rooms or anesthesia workstations.

The filters are supplied as single-use, sterile items and are compatible with MRI environments due to their non-magnetic construction. Available in multiple sizes and configurations, they are intended for use in anesthesia delivery systems and must be stored in a clean, dry environment as per manufacturer instructions. Authorized under FDA 510(k) clearance and MDD compliance, these filters adhere to strict regulatory standards for conduction filters in anesthetic applications.

Frequently asked questions

What are the primary uses of the Vented Millex-GV and Cathivex-GV filters in clinical settings?

These filters are designed specifically for anesthetic gas scavenging systems to remove volatile anesthetic agents from breathing circuits. Their purpose is to ensure patient safety by preventing the accumulation of gases in operating rooms or anesthesia workstations, thereby maintaining a clean and safe environment during procedures.

Are the Vented Millex-GV and Cathivex-GV filters reusable or single-use, and how should they be stored?

These filters are intended for single-use only. To maintain their sterility and performance, they must be stored in a clean, dry environment as instructed by the manufacturer. Proper storage conditions are critical to preserving their integrity before use.

Can these filters be used in MRI environments, and why?

Yes, these filters are designed to be compatible with MRI environments due to their non-magnetic construction. This feature ensures they can be safely used in facilities where magnetic resonance imaging is performed without interfering with the equipment or posing safety risks.

What regulatory pathways have these filters undergone, and what does that mean for their use?

The Vented Millex-GV and Cathivex-GV filters have undergone FDA 510(k) clearance and comply with the Medical Device Directive (MDD). This means they have been evaluated for safety and effectiveness by regulatory authorities and are classified as Class II medical devices under FDA regulations, ensuring they meet stringent standards for conduction filters in anesthetic applications.

Are there multiple sizes or configurations available for these filters, and how does that affect their application?

Yes, these filters are available in multiple sizes and configurations to accommodate various anesthesia delivery systems. The availability of different sizes ensures compatibility with a range of clinical setups, allowing healthcare providers to select the appropriate filter for their specific equipment and patient needs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Merck Millipore Ltd
FDA Applicant
Merck Millipore , Ltd.

Sources (2)

  • FDA 510(k) K133004 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026