Identifiers
- 510(k) Number
- K231629 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 091 Balloon Guide Catheter is a balloon catheter (DQY product code) designed for guiding intravascular catheters through peripheral and neurovascular systems. It features an inflatable balloon that facilitates precise catheter placement by temporarily occluding blood flow, ensuring stable positioning for interventions such as stent deployment. The device aids in navigating complex vascular anatomy, including small or tortuous vessels, where traditional guidewires may be insufficient. Its design supports both diagnostic and therapeutic procedures requiring controlled vessel access.
This catheter is supplied as a single-use, sterile device and is intended for use in interventional radiology and cardiology settings. The balloon dimensions and maximum inflation volume are clearly labeled on the product packaging. It is MRI-unsafe due to its metallic components and must not be used in magnetic resonance imaging environments. The device holds FDA 510(k) clearance (K231629) under the Special 510(k) pathway, with a substantially equivalent determination by the Cardiovascular Advisory Committee. Proper storage requires protection from moisture and mechanical damage, adhering to standard sterile catheter handling protocols.
Frequently asked questions
What is the primary purpose of the 091 Balloon Guide Catheter?
The 091 Balloon Guide Catheter is designed to guide intravascular catheters through peripheral and neurovascular systems, including small or tortuous vessels. Its inflatable balloon temporarily occludes blood flow, providing stable positioning for interventions like stent deployment during diagnostic and therapeutic procedures in interventional radiology and cardiology.
How is the 091 Balloon Guide Catheter supplied and what are its sterility and usage guidelines?
The 091 Balloon Guide Catheter is supplied as a single-use, sterile device. It must be handled under sterile conditions following standard catheter protocols to prevent contamination. Each package includes labeled balloon dimensions and maximum inflation volume for reference.
Can the 091 Balloon Guide Catheter be used in MRI environments?
No, the 091 Balloon Guide Catheter is MRI-unsafe due to its metallic components. It should never be used in magnetic resonance imaging environments, as this could pose significant safety risks to patients and operators.
What storage precautions should be taken for the 091 Balloon Guide Catheter?
The device must be stored in a dry environment, protected from moisture and mechanical damage. Adhere to standard sterile catheter handling protocols to maintain integrity until use. Avoid exposure to extreme temperatures or direct sunlight.
What regulatory clearance does the 091 Balloon Guide Catheter hold?
The 091 Balloon Guide Catheter holds FDA 510(k) clearance (K231629) under the Special 510(k) pathway, with a substantially equivalent determination by the Cardiovascular Advisory Committee. This clearance confirms its compliance with U.S. regulatory standards for intravascular catheters.
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: PDF October 31, 2023 EOSolutions, Corp. Garry Koroshec Senior Design ..., 091 Balloon Guide Catheter - Eosolutions | FDA Reference, 091 Balloon Guide Catheter (K231629) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231629 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eosolutions, Corp.
Sources (1)
- FDA 510(k) K231629 24 fields · synced Oct 1, 2026