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medtronic model 69575
Medtronic Vascular
Summary: The Medtronic Model 69575 is an inferior vena cava (IVC) filter used to prevent pulmonary embolism in patients with contraindications to anticoagulation. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K800944 ↗
Decision Date
September 26, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 69575 was cleared through the FDA 510(k) process on September 26, 1980. It is manufactured by Medtronic Vascular and classified as a Class III device under product code DTB.
What It Is
The Medtronic Model 69575 is an IVC filter designed to capture blood clots that may travel from the lower extremities to the lungs, thereby preventing pulmonary embolism. It is implanted in the inferior vena cava, the large vein carrying blood from the lower body to the heart. The filter is typically made of metal and is designed to be either permanent or retrievable, depending on the patient's needs.
Clinical Applications
This device is commonly used in patients who are at high risk of developing pulmonary embolism but cannot take anticoagulant medications due to contraindications such as active bleeding or recent surgery. It is often placed in a hospital setting by interventional radiologists or vascular surgeons. Patients who may benefit include those with deep vein thrombosis (DVT) or those undergoing high-risk surgical procedures.
Indications for Use
The FDA indications for the Medtronic Model 69575 include preventing pulmonary embolism in patients with contraindications to anticoagulation therapy. It is particularly indicated for patients with a history of DVT or those at high risk of clot formation.
Practical Considerations
The Medtronic Model 69575 comes in various sizes to accommodate different patient anatomies. It is important to ensure compatibility with the patient's IVC diameter and consider the retrievability options if long-term placement is not intended. Placement technique requires fluoroscopic guidance for accurate positioning.
Frequently Asked Questions
What is Medtronic Model 69575 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 preventing pulmonary embolism in patients who cannot use anticoagulants.
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.