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spectranetics quick cross catheters models 518-032 518-033 518034 518-035 518-036 518-037 and 518-038
Spectranetics
Summary: The Spectranetics Quick Cross Catheters are medical devices used primarily in vascular procedures to facilitate the crossing of lesions. They are commonly used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K033678 ↗
Decision Date
February 23, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Spectranetics Quick Cross Catheters were cleared through the FDA 510(k) pathway on February 23, 2004. Manufactured by Spectranetics, these devices are classified as Class 2 under the product code DQY.
What It Is
The Spectranetics Quick Cross Catheters are designed to assist in the navigation and crossing of vascular lesions. These catheters are used in endovascular procedures to provide support and facilitate the delivery of other therapeutic devices. Their design allows for enhanced maneuverability and access within the vascular system, which is crucial in complex interventional procedures.
Clinical Applications
These catheters are commonly used in procedures involving the placement of venous stents, particularly in patients with peripheral artery disease or other vascular obstructions. Interventional cardiologists and radiologists frequently use them in hospital settings, especially in catheterization labs. They are suitable for adult patients who require intervention for vascular blockages.
Indications for Use
The FDA-cleared indications for these catheters include use in procedures that require crossing of vascular lesions. They are intended for patients with conditions such as peripheral artery disease, where there is a need to navigate through blocked or narrowed vessels.
Practical Considerations
The Quick Cross Catheters come in various sizes to accommodate different vessel diameters and lesion types. They are compatible with standard guidewires and can be used in conjunction with other interventional devices. Proper technique and familiarity with catheter navigation are essential for optimal performance.
Frequently Asked Questions
What is Spectranetics Quick Cross Catheters used for?
They are used to facilitate the crossing of vascular lesions during endovascular procedures.
What specialties typically use this device?
Interventional cardiology and interventional radiology specialists commonly use these catheters.
What are the FDA-cleared indications?
They are indicated for use in procedures requiring the crossing of vascular lesions, such as those found in peripheral artery disease.
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.