đź“‹ FDA Reference
seamed model 3000
Seamed
Summary: The Seamed Model 3000 is a medical device used for the retrieval of inferior vena cava (IVC) filters. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway 510K
Number K860462 ↗
Decision Date August 19, 1986
Product Code DTC
Device Class Class 2
Evidence 0 studies
The Seamed Model 3000 was cleared through the FDA 510k pathway on August 19, 1986. Manufactured by Seamed, it is classified as a Class 2 device under product code DTC.
What It Is
The Seamed Model 3000 is a specialized device designed for the retrieval of IVC filters. These filters are typically placed in the inferior vena cava to prevent pulmonary embolism by capturing blood clots. The device facilitates the safe and effective removal of these filters when they are no longer needed or if complications arise.
Clinical Applications
The Seamed Model 3000 is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in cases where temporary IVC filters need to be removed after the risk of clot migration has subsided. This device is crucial for patients who have had an IVC filter placed due to a high risk of pulmonary embolism and now require its retrieval.
Indications for Use
The FDA indications for the Seamed Model 3000 involve the retrieval of IVC filters. This device is intended for patients who have had an IVC filter placed and now need it removed, either due to the resolution of the initial condition or due to complications associated with the filter.
Practical Considerations
The Seamed Model 3000 is compatible with standard IVC filters and is typically available in sizes that accommodate various filter designs. Clinicians should be familiar with the retrieval technique and ensure that the device is compatible with the specific filter model used in the patient.
Frequently Asked Questions
What is Seamed Model 3000 used for?
The Seamed Model 3000 is used for the retrieval of inferior vena cava (IVC) filters.
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 the retrieval of IVC filters in patients who no longer need them or have experienced complications.
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.