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biocardia 8f morph dna deflectable guide catheter
Biocardia
Summary: The Biocardia 8F Morph DNA Deflectable Guide Catheter is a medical device used to facilitate the placement of other devices within the venous system. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K192774 ↗
Decision Date
January 7, 2020
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Biocardia 8F Morph DNA Deflectable Guide Catheter was cleared through the FDA 510k pathway on January 7, 2020. It is manufactured by Biocardia and classified as a Class 2 device.
What It Is
The Biocardia 8F Morph DNA Deflectable Guide Catheter is a specialized catheter designed to provide flexibility and maneuverability during procedures involving the venous system. It features a deflectable tip that allows for precise navigation and positioning, which is critical in complex vascular interventions. This device is particularly useful in procedures where access to difficult-to-reach areas is required.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology procedures, such as the placement of venous stents or other therapeutic devices. It is particularly useful in settings where precise navigation through the venous system is necessary, such as in patients with complex vascular anatomy or those requiring targeted interventions. The device is suitable for use in both inpatient and outpatient settings.
Indications for Use
The FDA indications suggest that this catheter is intended for use in facilitating the placement of other devices within the venous system. It is suitable for patients requiring interventions that involve the navigation and positioning of devices in the veins.
Practical Considerations
The Biocardia 8F Morph DNA Deflectable Guide Catheter is typically available in various lengths to accommodate different patient anatomies. It is compatible with standard guidewires and other interventional tools. Clinicians should be familiar with the catheter's deflection mechanism to optimize its use during procedures.
Frequently Asked Questions
What is the Biocardia 8F Morph DNA Deflectable Guide Catheter used for?
It is used to facilitate the placement of devices within the venous system, particularly in complex vascular procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The catheter is indicated for use in facilitating the placement of other devices within the venous system.
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.