đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Embolization of blood vessels when targeted vessel occlusion is clinically indicated.
- Use by trained clinicians during image-guided embolization procedures.
Clinical Applications
- Targeted occlusion of selected blood vessels during interventional radiology procedures.
- Embolization of vessels supplying hypervascular lesions when consistent with the device labeling and treatment plan.
- Embolization for selected vascular abnormalities when vessel occlusion is clinically indicated.
Practical Considerations
- The FDA record identifies the product under product code MQV; the exact formulation, particle characteristics, preparation instructions, and delivery-system compatibility should be confirmed in the current manufacturer labeling.
- Delivery requires appropriate image guidance and a catheter or delivery system compatible with the product's handling and setting characteristics.
- Operators should account for cement preparation, injection behavior, setting time, and the risk of unintended embolization or non-target vessel occlusion.
- Review contraindications, warnings, and precautions in the current instructions for use before treatment; patient-specific vascular anatomy and blood-flow dynamics are important.
- MRI safety and conditional-use information should be verified in the current labeling. Do not assume MRI compatibility from the material name alone.
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.