📋 FDA Reference
Stiffer Coaxial Micro-Introducer Kit
Enpath Medical
Summary: The stiffer coaxial micro-introducer kit is a medical device used primarily by interventional radiologists for procedures involving embolization coils. It facilitates the introduction of devices into the vascular system.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K071574 ↗
Decision Date ?
July 5, 2007
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on July 5, 2007. Manufactured by Enpath Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The stiffer coaxial micro-introducer kit is a specialized tool designed to aid in the insertion of medical devices into the vascular system. It consists of a sheath and dilator that provide a stable and controlled pathway for the introduction of embolization coils and other interventional tools. Its stiffer construction allows for enhanced control and precision during procedures.
FDA-Cleared Indications
- Facilitation of embolization-coil introduction into the vascular system.
Clinical Applications
- Providing vascular access for placement of embolization coils.
- Supporting catheter-based treatment of aneurysms and other vascular abnormalities when embolization coils are indicated.
- Creating a stable access pathway during interventional radiology or neurointerventional procedures involving coil delivery.
Practical Considerations
- Select the sheath and dilator size to match the embolization coil delivery system and other compatible devices.
- The stiffer construction may improve support and control but requires careful advancement to reduce the risk of vessel injury.
- Use fluoroscopic or other appropriate imaging guidance and follow the device labeling and institutional protocols.
- MRI safety depends on the specific kit materials and labeling; confirm MR Safe, MR Conditional, or MR Unsafe status before scanning.
- Potential contraindications and complications relate to vascular access and device introduction, including bleeding, infection, vessel injury, thrombosis, and embolization.
Procedures that use this device
Frequently Asked Questions
What is the stiffer coaxial micro-introducer kit used for?
It is used to facilitate the introduction of embolization coils into the vascular system during interventional radiology procedures.
What specialties typically use this device?
Interventional radiologists primarily use this device in hospital settings for vascular interventions.
What are the FDA-cleared indications?
The device is indicated for use in introducing embolization coils into the vascular system to treat conditions such as aneurysms.
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.