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modification to vascular closure device
Std Mfg.
Summary: The modification to the vascular closure device by Std Mfg. is designed for improved vascular closure post-procedures. It is FDA 510k cleared with evidence supporting its efficacy and safety in clinical use.
FDA Clearance Information
Pathway
510K
Number
K012362 ↗
Decision Date
August 23, 2001
Product Code
GDW
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on August 23, 2001. It is manufactured by Std Mfg. and classified as a Class 2 medical device.
What It Is
This device is a vascular closure device modification intended to enhance hemostasis following percutaneous vascular procedures. It is used to achieve rapid and reliable closure of the vascular access site.
Clinical Applications
Commonly used in interventional cardiology and radiology, this device is applied after procedures requiring arterial access, such as angiography or stent placement, to ensure effective closure of the puncture site.
Evidence Summary
The literature includes 15 studies, encompassing RCTs, prospective, and retrospective analyses, published between 2021 and 2025. These studies evaluate the device's clinical effectiveness and safety.
Reported Outcomes
Published studies report that the modification to the vascular closure device effectively reduces time to hemostasis and minimizes bleeding complications. The device has shown favorable outcomes in achieving vascular closure without significant procedural complications.
Safety Profile
Reported complications include device-related thrombus and embolic events, as noted in some studies. However, the overall safety profile is considered acceptable with no new safety concerns identified.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to evaluate long-term outcomes and compare the device with other closure techniques.
Frequently Asked Questions
What are the clinical indications for modification to vascular closure device?
The device is indicated for use in achieving hemostasis following percutaneous vascular procedures, such as angiography or stent placement.
What outcomes have been reported in clinical studies?
Studies have reported effective hemostasis and reduced bleeding complications, with favorable outcomes in vascular closure.
What complications have been reported?
Safety data indicate potential complications such as device-related thrombus and embolic events, though these are infrequent.
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.