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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 ?
510(k)
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.
FDA-Cleared Indications
- Use for closure and hemostasis of a percutaneous vascular access site following an intravascular procedure.
- Use after procedures involving arterial catheterization when closure of the puncture site is clinically appropriate.
Clinical Applications
- Closure of an arterial puncture site after diagnostic angiography.
- Hemostasis after percutaneous vascular procedures performed through arterial access.
- Closure following interventional procedures such as stent placement when the device is compatible with the access site and procedure.
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.
Practical Considerations
- The specific access vessel, sheath size, puncture location and anatomy must be compatible with the device labeling.
- Operators should confirm that the puncture is in an appropriate segment of the vessel and not through a branch vessel, heavily diseased segment or other unsuitable anatomy.
- Contraindications and precautions depend on the device's original labeling and may include infection at the access site, significant vascular disease, abnormal anatomy or inability to locate the puncture accurately.
- MRI safety cannot be determined from the FDA 510(k) record alone; review the current device labeling for MR Safe, MR Conditional or MR Unsafe status.
- The device is intended for single use. Handling, deployment and removal must follow the manufacturer's instructions and institutional protocols.
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.