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candela sheath sets
Candela Laser
Summary: Candela Sheath Sets are medical devices used primarily in vascular procedures, particularly for venous stenting. They are typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K950634 ↗
Decision Date
March 1, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Candela Sheath Sets were cleared through the FDA 510(k) pathway on March 1, 1995. Manufactured by Candela Laser, this Class 2 device is categorized under product code DQY.
What It Is
Candela Sheath Sets are designed to facilitate the insertion and placement of venous stents. These devices consist of a sheath that provides a conduit for the stent delivery system, ensuring precise placement within the vascular system. The sheath is typically made of biocompatible materials to minimize the risk of adverse reactions.
Clinical Applications
Candela Sheath Sets are commonly used in procedures involving the treatment of venous obstructions, such as in patients with chronic venous insufficiency or post-thrombotic syndrome. They are primarily utilized in hospital settings by specialists in interventional radiology and vascular surgery. The device aids in the accurate deployment of stents in the venous system, improving patient outcomes.
Indications for Use
The FDA indications suggest that Candela Sheath Sets are intended for use in procedures requiring venous stenting. This includes patients with conditions like venous blockages or narrowing that necessitate the placement of a stent to restore proper blood flow.
Practical Considerations
Candela Sheath Sets come in various sizes to accommodate different patient anatomies and procedural requirements. They are compatible with a range of stent delivery systems. Clinicians should be familiar with the specific technique for sheath insertion and stent deployment to ensure optimal results.
Frequently Asked Questions
What is Candela Sheath Sets used for?
Candela Sheath Sets are used for the insertion and placement of venous stents in vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use Candela Sheath Sets.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting, such as treating venous obstructions.
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.