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dsm biomedical calcium phosphate cement with microspheres
Kensey Nash Corporation Dba Dsm Biomedical
Summary: The DSM Biomedical Calcium Phosphate Cement with Microspheres is a medical device used for embolization procedures. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K173572 ↗
Decision Date
May 9, 2018
Product Code
MQV
Device Class
Class 2
Evidence
0 studies
The DSM Biomedical Calcium Phosphate Cement with Microspheres was cleared through the FDA 510k pathway on May 9, 2018. It is manufactured by Kensey Nash Corporation and is classified as a Class 2 device under product code MQV.
What It Is
This device is a calcium phosphate cement that incorporates microspheres, designed for use in embolization procedures. The cement is biocompatible and can be used to occlude blood vessels, thereby reducing blood flow to targeted areas. Its unique formulation allows for precise delivery and controlled embolization, which is crucial in various therapeutic interventions.
Clinical Applications
The device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures requiring the embolization of blood vessels, such as in the treatment of arteriovenous malformations or hypervascular tumors. The device is suitable for adult patients and can be used in both inpatient and outpatient settings.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in embolization procedures. It is suitable for patients requiring targeted vessel occlusion, such as those with certain types of tumors or vascular abnormalities.
Practical Considerations
Clinicians should be aware of the device's compatibility with standard embolization catheters and delivery systems. Proper technique is essential to ensure effective embolization and to minimize potential complications. The cement's setting time and handling characteristics should be considered during procedures.
Frequently Asked Questions
What is DSM Biomedical Calcium Phosphate Cement used for?
It is used for embolization procedures to occlude blood vessels in targeted therapeutic interventions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to occlude blood vessels in patients with vascular abnormalities or tumors.
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.