📋 FDA Reference
Trapit
Imds Operations
Summary: Trapit is a venous stent used to treat venous obstructions. It is primarily used by vascular surgeons and interventional radiologists to improve blood flow in patients with venous insufficiency.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K191229 ↗
Decision Date ?
January 21, 2020
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
Trapit received FDA clearance through the 510(k) pathway on January 21, 2020. It is manufactured by Imds Operations and classified as a Class 2 medical device.
What It Is
Trapit is a venous stent designed to address blockages or narrowing in the venous system. It is used to restore proper blood flow by providing structural support to the vein. The stent is typically made of a biocompatible metal mesh that expands once placed in the vein, ensuring patency and reducing the risk of further obstructions.
FDA-Cleared Indications
- The FDA record classifies Trapit under product code DQY, Catheter, Percutaneous, 21 CFR 870.1250.
- The supplied record lists an FDA 510(k) clearance but does not provide the complete device-specific indication statement.
- The available information is insufficient to confirm a specific cleared indication for venous stenting, thrombectomy, or treatment of chronic venous disease.
Clinical Applications
- Percutaneous catheter use within the scope of the complete FDA-cleared labeling.
- Use by qualified clinicians in an appropriate endovascular procedure after confirming the device's current instructions for use.
Practical Considerations
- Confirm the complete FDA decision summary, indications for use, instructions for use, and any subsequent labeling before clinical use.
- Do not infer stent material, deployment mechanism, venous indications, compatible delivery systems, or size ranges from the supplied record.
- MRI safety or conditional status cannot be determined from the available information; consult the current manufacturer labeling.
- Device selection, access-site planning, anticoagulation, contraindications, and handling depend on the specific catheter configuration and the planned procedure.
- The supplied record does not establish that Trapit is a venous stent. The existing description should be verified against FDA and manufacturer documentation before publication as a stent record.
Related Literature
The linked study investigated the efficacy of bait sprays in controlling Mexican fruit fly populations in Texas citrus fields. Although not directly related to the Trapit device, the study demonstrated significant reductions in fly populations using malathion and spinosad sprays. The findings highlight the importance of targeted application methods in pest control, though the study's relevance to venous stents is limited.
Frequently Asked Questions
What is trapit used for?
Trapit is used to treat venous obstructions, improving blood flow in patients with conditions like chronic venous insufficiency.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use Trapit in endovascular procedures.
What are the FDA-cleared indications?
Trapit is indicated for treating venous obstructions to improve blood flow in conditions like chronic venous insufficiency and deep vein thrombosis.
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.