📋 FDA Reference
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 ?
510(k)
Number ?
K950634 ↗
Decision Date ?
March 1, 1995
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous vascular access for the introduction and guidance of intravascular catheters or other compatible devices.
- Use in catheter-based procedures when a sheath is needed to maintain access to a blood vessel.
Clinical Applications
- Obtaining and maintaining percutaneous access during endovascular procedures.
- Providing a conduit for compatible catheter and delivery systems.
- Supporting catheter-based treatment of vascular disease when the selected sheath size and design are appropriate.
- Use by trained clinicians in hospital or procedure-room settings under imaging guidance.
Practical Considerations
- Choose the sheath diameter and working length based on the access vessel, target anatomy, and outer diameter of the device being introduced.
- Confirm compatibility with the intended catheter, guidewire, stent delivery system, and any hemostatic valve or dilator supplied with the set.
- Insertion is generally performed using percutaneous technique, commonly with ultrasound and fluoroscopic guidance, local anesthesia, and sedation when clinically appropriate.
- Review the product-specific instructions for use, including limitations, contraindications, flushing, and handling requirements.
- MRI safety cannot be determined from the available FDA record. Check the current labeling for the exact set and confirm whether it is MR Safe, MR Conditional, or not evaluated before MRI.
Procedures that use this device
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.