📋 FDA Reference
Vascular Solutions Twin-Pass Dual Access Catheter
Summary: The Vascular Solutions Twin-Pass Dual Access Catheter is a specialized catheter used in vascular procedures to facilitate dual access to a vessel. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K052257 ↗
Decision Date ?
November 23, 2005
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Twin-Pass Dual Access Catheter by Vascular Solutions was cleared via the FDA 510(k) pathway on November 23, 2005. It is a Class 2 medical device under product code DQY.
What It Is
The Twin-Pass Dual Access Catheter is a dual-lumen catheter designed to provide simultaneous access to a vessel through a single entry point. It allows clinicians to perform complex vascular interventions by facilitating the delivery of guidewires and other devices. The catheter's design enables precise navigation and positioning within the vascular system, making it a valuable tool in interventional procedures.
FDA-Cleared Indications
- For percutaneous vascular procedures requiring dual access to a blood vessel through a single access site.
- For the delivery or exchange of guidewires and other interventional devices during vascular procedures.
- The FDA record identifies this as a Class II percutaneous catheter under product code DQY.
Clinical Applications
- Providing two access pathways during complex percutaneous vascular interventions.
- Facilitating guidewire placement, exchange, or control within a treated vessel.
- Supporting endovascular procedures in which simultaneous access is needed through one vascular entry site.
- Use with other compatible catheters, guidewires, or vascular devices in a hospital or interventional procedure setting.
Practical Considerations
- The catheter is available in different configurations and sizes; the operator selects the option based on vessel size, access route, and the devices being used.
- Compatibility with guidewires and other devices must be confirmed from the specific product labeling before use.
- The device is inserted percutaneously under fluoroscopic or other appropriate imaging guidance by clinicians trained in endovascular techniques.
- The FDA record provided does not establish MRI safety. MRI use should be avoided unless the exact device and conditions are identified in the current manufacturer labeling.
- Risks are similar to other percutaneous vascular catheters and may include bleeding, hematoma, vessel injury, thrombosis, embolization, infection, contrast reaction, or loss of access.
Procedures that use this device
Frequently Asked Questions
What is the Vascular Solutions Twin-Pass Dual Access Catheter used for?
It is used to provide dual access to a vessel during complex vascular interventions, such as stent placements.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring dual access to a vessel, such as venous stent placements.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.