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perqseal introducers
Vivasure Medical
Summary: PerQSeal Introducers are used for vascular closure following large-bore catheter procedures. Primarily used by interventional radiologists and cardiologists, they aid in achieving hemostasis efficiently.
FDA Clearance Information
Pathway
510K
Number
K252309 ↗
Decision Date
October 23, 2025
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The PerQSeal Introducers by Vivasure Medical received FDA clearance via the 510(k) pathway on October 23, 2025. It is classified as a Class 2 medical device.
What It Is
The PerQSeal Introducers are medical devices designed for vascular closure following procedures that require large-bore catheter access. They function by sealing the puncture site in the vessel wall, thereby achieving hemostasis. This device is particularly useful in reducing the time to ambulation and discharge, enhancing patient recovery post-procedure.
Clinical Applications
Commonly used in interventional cardiology and radiology, PerQSeal Introducers are employed during procedures like transcatheter aortic valve replacement (TAVR) or endovascular aneurysm repair (EVAR). These devices are crucial in settings where large-bore arterial access is required, and rapid closure is essential to prevent complications. They are suitable for adult patients undergoing complex vascular interventions.
Indications for Use
The FDA indications suggest that PerQSeal Introducers are intended for use in closing large vascular access sites following catheter-based procedures. This is particularly relevant for patients undergoing interventions that require large-bore arterial access.
Practical Considerations
PerQSeal Introducers are available in various sizes to accommodate different vessel diameters. They are compatible with standard large-bore catheters and require specific deployment techniques to ensure effective closure. Clinicians should be trained in the device's use to optimize outcomes.
Related Literature
The linked study, 'Safety and Performance Study of Large Hole Vascular Closure Device FIV,' aimed to evaluate the safety and effectiveness of the PerQSeal Introducers. Although the abstract is not available, such studies typically assess hemostasis time, complication rates, and patient outcomes. Limitations may include sample size and the absence of long-term follow-up data.
Frequently Asked Questions
What is PerQSeal Introducers used for?
PerQSeal Introducers are used for vascular closure following large-bore catheter procedures to achieve hemostasis.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use PerQSeal Introducers.
What are the FDA-cleared indications?
The device is indicated for closing large vascular access sites post-catheter-based procedures.
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.