đź“‹ FDA Reference
secureloc advancintroducer
Specialized Health Products
Summary: The SecureLoc Advance Introducer is a medical device used for vascular access, primarily by interventional radiologists and cardiologists. It facilitates the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K050023 ↗
Decision Date
February 18, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The SecureLoc Advance Introducer was cleared through the FDA 510k pathway on February 18, 2005. It is manufactured by Specialized Health Products and classified as a Class 2 device under product code DYB.
What It Is
The SecureLoc Advance Introducer is a vascular access device designed to aid in the insertion of catheters and other medical devices into the vascular system. It typically consists of a sheath and dilator, allowing for smooth and secure access to blood vessels. This device is crucial in procedures requiring stable and reliable vascular entry, minimizing trauma to the vessel.
Clinical Applications
This device is commonly used in interventional radiology and cardiology procedures, such as angiography, embolization, and the placement of stents or coils. It is particularly useful in hospital settings where precise vascular access is needed, such as in the treatment of vascular diseases or during minimally invasive surgeries. Patients who require repeated vascular access or have complex vascular anatomy may benefit from its use.
Indications for Use
The FDA indications suggest that the SecureLoc Advance Introducer is intended for patients needing vascular access for diagnostic or therapeutic procedures. It is suitable for those undergoing procedures that require the introduction of catheters or other devices into the vascular system.
Practical Considerations
Clinicians should consider the appropriate size of the introducer based on the patient's vessel size and the procedure being performed. Compatibility with other vascular devices should be verified. Proper technique in insertion and removal is essential to minimize vascular trauma and complications.
Frequently Asked Questions
What is SecureLoc Advance Introducer used for?
It is used for providing vascular access to facilitate the introduction of catheters and other devices into the vascular system.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
It is indicated for use in patients requiring vascular access for diagnostic or therapeutic procedures involving catheter or device introduction.
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.