đź“‹ FDA Reference
hemaquet tm and hemaflex tm introducers
C.R. Bard
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
510K
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.
Clinical Applications
These introducers are commonly used in interventional radiology and cardiology for procedures like embolization, where precise catheter placement is crucial. They are also used in settings such as hospitals and specialized clinics, particularly for patients requiring vascular interventions. The devices are suitable for a wide range of patient populations, including those with vascular diseases or conditions requiring diagnostic imaging.
Indications for Use
The FDA indications for these devices include facilitating the introduction of catheters into the vascular system. They are used in patients who require vascular access for diagnostic or therapeutic procedures, such as embolization or angiography.
Practical Considerations
The Hemaquet TM and Hemaflex TM Introducers come in various sizes to accommodate different vessel diameters and catheter sizes. They are compatible with standard catheters and are designed for ease of use, ensuring minimal vessel trauma during insertion. Clinicians should be familiar with the technique of introducer placement to optimize outcomes.
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.