📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Closure of large-bore vascular access sites following catheter-based procedures.
- Achieving hemostasis at the vascular puncture site after removal of large-bore access devices.
Clinical Applications
- Closure of femoral arterial access sites after large-bore catheter procedures.
- Vascular closure after transcatheter aortic valve replacement when large-bore arterial access has been used.
- Vascular closure after endovascular aneurysm repair when large-bore arterial access has been used.
- Hemostasis after other catheter-based vascular interventions requiring large-bore access, when the access site and patient meet the device labeling.
Practical Considerations
- The appropriate device size depends on the access-site anatomy, vessel diameter, sheath or catheter size, and the specific product instructions for use.
- The device is intended for use by trained clinicians familiar with large-bore vascular access and closure techniques.
- Imaging and assessment of the access vessel may be needed before deployment, particularly when there is concern for calcification, stenosis, dissection, thrombosis, or bleeding.
- The FDA record supplied here does not establish MRI safety. MRI conditions should be confirmed in the current manufacturer labeling before scanning.
- Patient selection and contraindications should follow the current FDA-cleared instructions for use; alternative management may include manual or mechanical compression, another closure device, covered stent treatment, or surgical repair.
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.