📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Retrieval of an implanted inferior vena cava filter when removal is clinically indicated.
Clinical Applications
- Endovascular retrieval of an IVC filter after the temporary risk of pulmonary embolism has decreased.
- Removal of an IVC filter when the filter is no longer clinically needed.
- Retrieval of an IVC filter when filter-related complications require removal, when technically feasible.
Practical Considerations
- The device must be compatible with the specific IVC filter design and the filter's retrieval hook or other retrieval feature.
- Retrieval is performed under fluoroscopic or other appropriate imaging guidance, typically through venous access such as the internal jugular or femoral vein.
- Clinicians should evaluate filter position, tilt, embedment, fracture, penetration, thrombus, and caval patency before attempting retrieval.
- The record provided does not establish MRI safety, specific device sizes, or compatibility with every IVC filter; consult the current labeling and device instructions.
- Contraindications and precautions depend on the patient's anatomy, thrombus burden, filter condition, bleeding risk, and the manufacturer's instructions.
Procedures that use this device
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.