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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
510K
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.
Clinical Applications
Commonly used in procedures requiring arterial or venous access, such as cardiac catheterizations and transcatheter aortic valve replacements, the device aids in achieving rapid hemostasis and reducing time to ambulation.
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.
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.