đź“‹ FDA Reference
model 366-28 adaptaid tm step-down adapter
Intermedics
Summary: The Model 366-28 Adaptaid TM Step-Down Adapter is a medical device used primarily in vascular procedures, specifically for the placement of IVC filters. It is utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K864047 ↗
Decision Date
November 3, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on November 3, 1986, by Intermedics. It is classified as a Class III device under product code DTB.
What It Is
The Model 366-28 Adaptaid TM Step-Down Adapter is designed to facilitate the placement of inferior vena cava (IVC) filters. It acts as a connector or adapter in the procedural setup, ensuring compatibility between different components of the vascular intervention system. This device is crucial in maintaining the integrity and functionality of the procedural equipment.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the placement of IVC filters, which are used to prevent pulmonary embolism in patients with deep vein thrombosis. The device is typically employed in hospital settings, catering to adult patients who are at risk of thromboembolic events.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring the placement of IVC filters. It is suitable for patients who are at risk of developing pulmonary embolism due to deep vein thrombosis or other thromboembolic conditions.
Practical Considerations
The Model 366-28 Adaptaid TM Step-Down Adapter is designed to be compatible with standard IVC filter placement systems. Clinicians should ensure the compatibility of the adapter with existing procedural equipment and be familiar with its integration into the vascular intervention setup.
Frequently Asked Questions
What is Model 366-28 Adaptaid TM Step-Down Adapter used for?
It is used to facilitate the placement of IVC filters in vascular procedures.
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 procedures requiring the placement of IVC filters to prevent pulmonary embolism.
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.