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biocardia morph universal deflectable guide catheter
Biocardia
Summary: The Biocardia Morph Universal Deflectable Guide Catheter is a versatile tool used in interventional cardiology and radiology for navigating vascular pathways. It is primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K042553 ↗
Decision Date
February 17, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Biocardia Morph Universal Deflectable Guide Catheter was cleared through the FDA 510(k) pathway on February 17, 2005. Manufactured by Biocardia, it is classified as a Class 2 device under product code DQY.
What It Is
The Biocardia Morph Universal Deflectable Guide Catheter is a medical device designed to assist in the navigation of vascular pathways during interventional procedures. It features a deflectable tip that allows for precise maneuvering within the vasculature, enhancing access to target sites. This catheter is particularly useful in complex procedures where flexibility and control are essential.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures such as stent placements and angiography. It is particularly beneficial in cases requiring access to difficult-to-reach areas within the venous system. The catheter is suitable for use in both adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The FDA-cleared indications for this device include its use in navigating the venous system to facilitate the placement of stents and other interventions. It is designed for patients requiring precise vascular access during interventional procedures.
Practical Considerations
The Biocardia Morph Universal Deflectable Guide Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard interventional equipment, and clinicians should be familiar with its deflection mechanism to optimize its use during procedures.
Frequently Asked Questions
What is the Biocardia Morph Universal Deflectable Guide Catheter used for?
It is used for navigating vascular pathways during interventional procedures, such as stent placements and angiography.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in navigating the venous system to facilitate stent placements and other vascular interventions.
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.