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Vascular Closure Device
Std Mfg.
Summary: The vascular closure device by Std Mfg. is used to achieve hemostasis after vascular procedures. It is FDA 510k cleared and supported by 15 studies, highlighting its efficacy in reducing time to ambulation and managing vascular access complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K003169 ↗
Decision Date ?
December 8, 2000
Product Code ?
GDW
Device Class ?
Class 2
Evidence ?
0 studies
The vascular closure device by Std Mfg. was cleared through the FDA 510k pathway on December 8, 2000. It is classified as a Class 2 medical device under product code GDW.
What It Is
The vascular closure device is designed to facilitate hemostasis following vascular procedures. It operates by mechanically sealing the access site, reducing the need for manual compression and enabling quicker patient recovery.
FDA-Cleared Indications
- Achieve hemostasis at a vascular access site after catheter-based vascular procedures.
- Mechanically close or seal the access-site puncture after vascular access is no longer needed.
Clinical Applications
- Hemostasis after arterial catheterization procedures.
- Hemostasis after venous catheterization procedures when consistent with the device labeling.
- Closure of femoral vascular access sites after interventional cardiology procedures.
- Closure of vascular access sites after other endovascular procedures using compatible access techniques.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, systematic reviews, and meta-analyses, published between 2023 and 2025. These studies evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the vascular closure device effectively reduces time to ambulation and manages vascular access complications in procedures like atrial fibrillation ablation and transcatheter aortic valve replacement. Comparative studies show mixed results between plug-based and suture-based devices.
Safety Profile
Reported complications include variable rates of vascular access site complications, such as bleeding and hematoma formation. The literature notes variability in complication rates, often based on the type of procedure and device used.
Evidence Limitations
The evidence is limited by small sample sizes and variability in study design. Further research is needed to establish long-term outcomes and compare efficacy across different types of vascular closure devices.
Practical Considerations
- The access-vessel diameter, puncture location, sheath size, and device model must match the manufacturer's instructions for use.
- Imaging or angiographic assessment may be needed to confirm suitable anatomy and exclude complications before deployment.
- Contraindications and precautions can include infection at the access site, inadequate vessel size, significant peripheral arterial disease, puncture outside the appropriate vessel segment, or inability to identify the access tract.
- The device is available in model-specific sizes and configurations; compatibility with the introducer sheath and access system must be verified.
- MRI safety depends on the specific device materials and labeling. Confirm the exact model's MR Safe, MR Conditional, or MR Unsafe status before MRI.
Frequently Asked Questions
What are the clinical indications for vascular closure device?
The device is indicated for achieving hemostasis following procedures requiring arterial or venous access, such as cardiac catheterizations and transcatheter aortic valve replacements.
What outcomes have been reported in clinical studies?
Studies report reduced time to ambulation and effective management of vascular access complications, with mixed results in comparisons between different closure device types.
What complications have been reported?
Safety data indicate complications such as bleeding and hematoma formation, with variability based on procedure type and device used.
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.