đź“‹ FDA Reference
model 3100 series sheath introducer kits models 3110 3130
Cryocor
Summary: The Model 3100 Series Sheath Introducer Kits by Cryocor are used for vascular access in interventional procedures. They are primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K040552 ↗
Decision Date
May 28, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Model 3100 Series Sheath Introducer Kits, manufactured by Cryocor, were cleared via the FDA 510(k) pathway on May 28, 2004. They are classified as Class 2 medical devices under product code DYB.
What It Is
The Model 3100 Series Sheath Introducer Kits are medical devices designed to facilitate vascular access for interventional procedures. These kits typically include a sheath, dilator, and guidewire, allowing clinicians to introduce catheters or other instruments into the vascular system with minimal trauma. The sheath provides a stable conduit through which various diagnostic or therapeutic devices can be passed.
Clinical Applications
These sheath introducer kits are commonly used in procedures requiring vascular access, such as angiography, embolization, and catheter-based interventions. Interventional radiologists and cardiologists frequently use them in hospital settings for both diagnostic and therapeutic purposes. They are suitable for a wide range of patient populations, including those undergoing treatment for vascular diseases or requiring embolization procedures.
Indications for Use
The FDA indications for these kits involve their use in procedures requiring vascular access, particularly where embolization coils or other devices need to be introduced into the vascular system. They are intended for patients requiring interventional procedures to manage vascular conditions.
Practical Considerations
The sheath introducer kits come in various sizes to accommodate different patient anatomies and procedural requirements. Compatibility with other devices, such as catheters and guidewires, is crucial, and clinicians should ensure that all components are appropriately sized. Proper technique in inserting and securing the sheath is essential to minimize complications.
Frequently Asked Questions
What is the Model 3100 Series Sheath Introducer Kits used for?
They are used for vascular access in interventional procedures, allowing the introduction of catheters and other devices into the vascular system.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use these devices in hospital settings.
What are the FDA-cleared indications?
The kits are indicated for use in procedures requiring vascular access, particularly for introducing embolization coils and other devices into the vascular system.
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.