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Hemaquet Tm and Hemaflex Tm Introducers
Summary: The Hemaquet TM and Hemaflex TM Introducers are medical devices used primarily in vascular procedures to facilitate the introduction of catheters or other instruments. They are typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K897041 ↗
Decision Date ?
March 16, 1990
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Hemaquet TM and Hemaflex TM Introducers were cleared through the FDA 510(k) pathway on March 16, 1990. Manufactured by C.R. Bard, these devices are classified as Class 2 under product code DYB.
What It Is
The Hemaquet TM and Hemaflex TM Introducers are specialized medical devices designed to aid in the insertion of catheters or other instruments into the vascular system. These introducers provide a stable and secure pathway, minimizing trauma to the vessel and ensuring precise placement of the catheter. They are essential tools in procedures requiring vascular access, such as angiography or embolization.
FDA-Cleared Indications
- Facilitate the introduction of catheters into the vascular system.
- Provide vascular access for diagnostic or therapeutic procedures requiring catheter placement.
Clinical Applications
- Obtaining vascular access for angiography and other catheter-based imaging procedures.
- Providing access for embolization procedures.
- Introducing vascular catheters or other compatible instruments into the vessel.
- Maintaining a stable access pathway during an interventional vascular procedure.
Practical Considerations
- Introducers are available in different sizes; the selected size must match the access vessel and the diameter of the catheter or instrument being used.
- Placement is generally performed using sterile technique and imaging guidance, commonly with a guidewire and fluoroscopy or ultrasound.
- Compatibility depends on the introducer's inner diameter, length, valve or dilator design, and the catheter or instrument manufacturer’s specifications.
- Potential access-site complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and pseudoaneurysm.
- MRI safety and the device's labeled conditions should be confirmed in the current product instructions before MRI. These introducers are typically single-use devices and should not be reused or resterilized unless specifically labeled otherwise.
Procedures that use this device
Frequently Asked Questions
What is Hemaquet TM and Hemaflex TM Introducers used for?
These devices are used to facilitate the insertion of catheters into the vascular system, primarily for procedures like embolization and angiography.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use these introducers in vascular procedures.
What are the FDA-cleared indications?
The devices are indicated for facilitating the introduction of catheters into the vascular system for diagnostic or therapeutic procedures.
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.