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Daig Obturator Catheter Introducer
Daig
Summary: The Daig Obturator Catheter Introducer is a medical device used to facilitate the insertion of catheters into blood vessels. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K884494 ↗
Decision Date ?
February 22, 1989
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Daig Obturator Catheter Introducer was cleared through the FDA 510(k) pathway on February 22, 1989. It is manufactured by Daig and classified as a Class 2 device under product code DYB.
What It Is
The Daig Obturator Catheter Introducer is a medical device designed to assist in the insertion of catheters into the vascular system. It typically consists of a sheath and an obturator that guides the catheter into place, minimizing trauma to the vessel. This device is essential in procedures requiring vascular access, providing a stable pathway for catheter placement.
FDA-Cleared Indications
- Facilitates insertion of catheters into blood vessels.
- Provides vascular access for diagnostic or therapeutic catheter procedures.
- Supports catheter placement during procedures involving embolization coils.
Clinical Applications
- Obtaining vascular access for catheter-based diagnostic procedures such as angiography.
- Providing a pathway for catheter placement during embolization procedures.
- Supporting catheter-based vascular interventions that require stable access.
Practical Considerations
- Available sizes and dimensions must be matched to the patient's vessel size and the catheter or embolization system being used.
- The device is inserted using standard vascular-access techniques, with imaging guidance as appropriate for the procedure.
- Careful advancement and removal are necessary to reduce the risk of bleeding, vessel injury, dissection or thrombosis.
- MRI safety depends on the specific device materials and labeling; the FDA clearance information provided here does not establish that this device is MR safe or MR conditional.
- Contraindications, warnings, and handling instructions should be confirmed in the current manufacturer labeling before use.
Procedures that use this device
Frequently Asked Questions
What is the Daig Obturator Catheter Introducer used for?
It is used to facilitate the insertion of catheters into blood vessels, commonly in interventional radiology and cardiology procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device for vascular access during various procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating catheter insertion into blood vessels, particularly in procedures involving embolization coils.
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.