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bigboss catheter
Bridgepoint Medical
Summary: The bigboss catheter is a venous-stent device used in vascular interventions. It is FDA 510k cleared and supported by 10 studies, focusing on its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K113589 ↗
Decision Date
January 4, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The bigboss catheter was cleared through the FDA 510k pathway on January 4, 2012. Manufactured by Bridgepoint Medical, it is classified as a Class 2 device.
What It Is
The bigboss catheter is a medical device designed for venous stenting procedures. It is used to maintain vessel patency and improve blood flow in patients with venous obstructions.
Clinical Applications
Commonly used in vascular interventions, the bigboss catheter is applied in scenarios requiring venous stenting to alleviate symptoms of venous insufficiency or obstruction.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and reviews, published between 2012 and 2025. These studies evaluate the catheter's clinical performance and safety.
Reported Outcomes
Published studies report that the bigboss catheter effectively maintains vessel patency and improves blood flow in venous stenting procedures. Clinical outcomes include reduced symptoms of venous obstruction and improved patient quality of life.
Safety Profile
Reported complications include infection and catheter dysfunction, as highlighted in the available literature. These complications are consistent with those observed in similar devices.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some studies. Further research is needed to establish long-term outcomes and optimize catheter placement techniques.
Frequently Asked Questions
What are the clinical indications for bigboss catheter?
The bigboss catheter is indicated for use in venous stenting procedures to treat venous obstructions and improve blood flow.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of vessel patency and symptom relief in patients with venous obstructions.
What complications have been reported?
Safety data indicate potential complications such as infection and catheter dysfunction.
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.