← Back to catalogue

Occlusion Balloon Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142692

by Embolx, Inc.

Identifiers

510(k) Number
K142692 FDA 510(k)
FDA Product Code
MJN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4450 FDA 510(k)
Regulation Number
870.4450 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sniper Balloon Occlusion Microcatheter is an intravascular occluding catheter designed for temporary vascular occlusion. It is classified as a Class II medical device under FDA regulations (870.4450) and falls under the OpenFDA category of Catheter, Intravascular Occluding, Temporary. This device is engineered to navigate complex and distal vascular structures, providing precise occlusion during embolization procedures.

The Sniper Balloon Occlusion Microcatheter is supplied as a single-use device and is intended for use in interventional radiology and cardiology settings. It is regulated under the FDA’s 510(k) clearance process, with the device receiving Substantial Equivalence determination in the Cardiovascular advisory committee. The microcatheter is designed for temporary occlusion and is not intended for permanent implantation. No specific MRI safety information is provided in the available data.

Frequently asked questions

What types of medical procedures is the Sniper Balloon Occlusion Microcatheter designed to assist with, and why is it particularly useful in those settings?

The Sniper Balloon Occlusion Microcatheter is specifically engineered for temporary vascular occlusion during embolization procedures in interventional radiology and cardiology. Its design allows it to navigate complex and distal vascular structures, making it particularly useful in procedures where precise, localized occlusion is required, such as during vascular interventions where blood flow must be temporarily halted to isolate a specific area.

Is the Sniper Balloon Occlusion Microcatheter intended for repeated use, or is it a single-use device? How does this affect its handling and disposal?

The Sniper Balloon Occlusion Microcatheter is explicitly supplied as a single-use device. This means it is intended for one-time use in a single patient procedure, after which it must be discarded. Single-use design ensures patient safety by eliminating the risk of cross-contamination and reduces the need for reprocessing, simplifying handling and disposal protocols for healthcare providers.

What regulatory pathway was followed for the FDA clearance of this device, and which advisory committee was involved?

The Sniper Balloon Occlusion Microcatheter received FDA clearance through the 510(k) process, specifically under a Traditional review pathway. The device was determined to be Substantially Equivalent (SESE) to a legally marketed predicate and was reviewed by the Cardiovascular (CV) Advisory Committee, which specializes in evaluating cardiovascular-related medical devices.

Are there any specific storage requirements for the Sniper Balloon Occlusion Microcatheter, and what should clinicians consider when preparing it for use?

While the provided data does not explicitly detail storage requirements, as a single-use, sterile medical device, it should be stored in a clean, dry environment protected from contamination and extreme temperatures. Clinicians should ensure the packaging remains intact until immediate use and follow standard sterile field protocols to maintain sterility before deployment during procedures.

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. Sources consulted: Embolx | Sniper Balloon Microcatheter, Sniper® Balloon Occlusion Microcatheter | Embolx, FDA Clearance for Embolx's Next Gen Sniper Balloon Occlusion ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Embolx, Inc.

Sources (1)

  • FDA 510(k) K142692 24 fields · synced Oct 6, 2026