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picf 0860 pscf 0860 psc 0860 piaf 0860 psaf 0860
Ela Medical
Summary: The picf 0860 series by Ela Medical are inferior vena cava (IVC) filters used to prevent pulmonary embolism by capturing blood clots. They are typically used by interventional radiologists or vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K872731 ↗
Decision Date
September 15, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on September 15, 1987, by Ela Medical. It is classified as a Class III device under product code DTB.
What It Is
The picf 0860 series are IVC filters designed to prevent pulmonary embolism by trapping emboli (blood clots) that originate in the lower extremities. They are implanted in the inferior vena cava, the large vein that carries blood from the lower body to the heart. The filters are typically made of metal and have a conical shape to effectively capture clots while allowing normal blood flow.
Clinical Applications
These IVC filters are commonly used in patients who are at high risk for pulmonary embolism, especially when anticoagulation therapy is contraindicated or ineffective. They are often used in trauma patients, those with deep vein thrombosis, or patients undergoing surgery. The device is typically placed by interventional radiologists or vascular surgeons in hospital settings.
Indications for Use
The FDA indications suggest this device is for patients at risk of pulmonary embolism, particularly when anticoagulants cannot be used. It is suitable for individuals with deep vein thrombosis or those undergoing procedures that increase embolism risk.
Practical Considerations
The filters come in various sizes to accommodate different patient anatomies and are compatible with standard delivery systems used in vascular procedures. Placement technique requires fluoroscopic guidance to ensure proper positioning in the inferior vena cava.
Frequently Asked Questions
What is picf 0860 used for?
It is used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava.
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 patients at risk of pulmonary embolism, especially when anticoagulation is not an option.
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.