📋 FDA Reference
Fast-Cath Hemostasis Introducer
Daig
Summary: The Fast-Cath Hemostasis Introducer by Daig is a medical device used for vascular access and hemostasis during interventional procedures. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K920779 ↗
Decision Date ?
June 3, 1992
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Fast-Cath Hemostasis Introducer was cleared by the FDA through the 510(k) pathway on June 3, 1992. Manufactured by Daig, it is classified as a Class 2 medical device under product code DYB.
What It Is
The Fast-Cath Hemostasis Introducer is a device designed to facilitate vascular access and achieve hemostasis during catheter-based procedures. It consists of a sheath and dilator, allowing for smooth insertion into blood vessels. This device is essential in procedures requiring the introduction of catheters or other instruments into the vascular system, ensuring minimal bleeding and trauma at the access site.
FDA-Cleared Indications
- Vascular access during catheter-based diagnostic and interventional procedures.
- Introduction of catheters, guidewires, and other intravascular instruments into blood vessels.
- Hemostasis at the vascular access site after catheter-based procedures.
Clinical Applications
- Establishing vascular access for angiography and other endovascular procedures.
- Providing access for embolization procedures involving intravascular devices such as coils.
- Maintaining a protected access route for catheter-based treatment of vascular abnormalities.
- Supporting catheter and guidewire exchanges while helping limit bleeding at the puncture site.
Practical Considerations
- The appropriate sheath size should match the catheter or device being used, the target vessel, and the patient's anatomy.
- The device is intended for use by trained clinicians familiar with percutaneous vascular access and hemostasis techniques.
- Careful insertion and removal are important to reduce bleeding, vessel injury, infection, thrombosis, and other access-site complications.
- Compatibility with the planned guidewire, catheter, and interventional device should be confirmed before use.
- MRI safety depends on the specific model, materials, and whether the device remains in place; consult the current labeling and MRI conditions rather than assuming it is MRI safe.
Procedures that use this device
Frequently Asked Questions
What is the Fast-Cath Hemostasis Introducer used for?
It is used for vascular access and hemostasis during interventional procedures such as angiography and embolization.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
It is indicated for use in patients requiring vascular access for interventional procedures, especially where hemostasis is important.
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.