đź“‹ FDA Reference
arrow glidethru peel-away sheath dilator introducer
Arrow International (Subsidiary Of Teleflex Inc.)
Summary: The Arrow GlideThru Peel-Away Sheath Dilator Introducer is a medical device used to facilitate the insertion of catheters or other medical devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K122854 ↗
Decision Date
January 4, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Arrow GlideThru Peel-Away Sheath Dilator Introducer was cleared through the FDA 510(k) pathway on January 4, 2013. It is manufactured by Arrow International, a subsidiary of Teleflex Inc., and is classified as a Class II device.
What It Is
The Arrow GlideThru Peel-Away Sheath Dilator Introducer is designed to assist in the insertion of catheters into the vascular system. It features a peel-away sheath that simplifies the removal process once the catheter is in place. The device is engineered to minimize trauma to the vessel and improve the ease of catheter placement, which is crucial in procedures requiring vascular access.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures that require vascular access, such as the placement of central venous catheters or embolization coils. It is particularly useful in settings like hospitals and outpatient surgical centers, where quick and efficient catheter placement is necessary. The device is suitable for a wide range of patient populations, including those requiring long-term intravenous therapy or hemodynamic monitoring.
Indications for Use
The FDA-cleared indications for this device include facilitating the insertion of catheters into the vascular system. It is intended for patients who need vascular access for treatments such as medication administration, fluid management, or diagnostic procedures.
Practical Considerations
The Arrow GlideThru Peel-Away Sheath Dilator Introducer is available in various sizes to accommodate different catheter diameters and patient anatomies. Clinicians should ensure compatibility with the catheter being used and be familiar with the peel-away technique to optimize procedural efficiency and patient safety.
Frequently Asked Questions
What is the Arrow GlideThru Peel-Away Sheath Dilator Introducer used for?
It is used to facilitate the insertion of catheters into the vascular system, commonly in interventional radiology and cardiology procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists are the primary users of this device, especially in settings requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating catheter insertion into the vascular system for treatments like medication administration and fluid management.
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.