đź“‹ FDA Reference
Model 366-19 Adaptaid Adapter Sleeve
Intermedics
Summary: The Adaptaid Adapter Sleeve by Intermedics is a medical device used in conjunction with IVC filters. It is primarily used by interventional radiologists and vascular surgeons to facilitate the placement of these filters.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K860985 ↗
Decision Date ?
March 31, 1986
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Adaptaid Adapter Sleeve was cleared through the FDA 510(k) pathway on March 31, 1986. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Adaptaid Adapter Sleeve is a specialized medical device designed to assist in the placement of inferior vena cava (IVC) filters. These filters are used to prevent pulmonary embolism by capturing blood clots that travel from the lower extremities to the lungs. The adapter sleeve ensures a secure and precise fit during the insertion of the filter, enhancing procedural safety and efficacy.
FDA-Cleared Indications
- Use as an accessory during placement of compatible inferior vena cava filters.
- Use to assist with positioning or deployment of an IVC filter according to the compatible filter system's labeling.
Clinical Applications
- Accessory use during percutaneous IVC filter placement.
- Assistance with positioning and deployment of a compatible IVC filter in the inferior vena cava.
- Use during fluoroscopy-guided IVC filter procedures performed by trained clinicians.
Practical Considerations
- Compatibility must be confirmed with the specific IVC filter system and delivery components before use.
- The available size, dimensions and handling characteristics should be verified in the original device labeling or by the treating facility.
- Use requires fluoroscopic guidance and familiarity with venous access and IVC filter deployment technique.
- The sleeve is an accessory rather than a treatment for deep vein thrombosis or pulmonary embolism itself.
- MRI safety information is not established in the provided FDA record; consult the original labeling and the MRI safety information for the complete filter system before scanning.
Procedures that use this device
Frequently Asked Questions
What is the Adaptaid Adapter Sleeve used for?
It is used to facilitate the placement of inferior vena cava (IVC) filters, which help prevent pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients requiring IVC filter placement, particularly those at risk for pulmonary embolism and who cannot use anticoagulation therapy.
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.