📋 FDA Reference
Spectranetics Quick-Cross SUPPORT2 Catheters Models 518-065 and 518-066
Summary: The Spectranetics Quick-Cross Support2 Catheters are used in vascular procedures to facilitate the placement of guidewires and other devices. They are typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K072750 ↗
Decision Date ?
December 4, 2007
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Spectranetics Quick-Cross Support2 Catheters were cleared via the FDA 510(k) pathway on December 4, 2007. Manufactured by Spectranetics, these devices are classified as Class 2 under product code DQY.
What It Is
The Spectranetics Quick-Cross Support2 Catheters are designed to assist in the navigation and support of guidewires during vascular interventions. These catheters provide a conduit for guidewires and other devices to reach target sites within the vascular system. Their design allows for flexibility and support, which is crucial in navigating complex vascular anatomy.
FDA-Cleared Indications
- Used to facilitate the placement of guidewires and other devices during vascular procedures.
- Intended for percutaneous intravascular use in the vascular system.
Clinical Applications
- Supporting guidewire placement during percutaneous vascular interventions.
- Providing a conduit for advancing or exchanging compatible interventional devices.
- Helping navigate devices through challenging vascular anatomy during catheter-based treatment.
Practical Considerations
- The models have different size and length specifications; clinicians should confirm the model-specific labeling before use.
- Use only with guidewires and other devices that are compatible with the catheter's lumen and specifications.
- The catheter is manipulated under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- MRI safety depends on the complete device labeling and whether the catheter remains in the patient; confirm current manufacturer information before MRI.
- Contraindications, warnings, and precautions should be reviewed in the model-specific instructions for use, including risks of vascular injury, bleeding, thrombosis, infection, and device malfunction.
Procedures that use this device
Frequently Asked Questions
What is Spectranetics Quick-Cross Support2 Catheters used for?
These catheters are used to facilitate the placement of guidewires and other devices during vascular interventions.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use these catheters in their procedures.
What are the FDA-cleared indications?
These catheters are indicated for use in facilitating the placement of guidewires and other devices in vascular procedures.
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.