Identity
- Trade Name
- CLOSER VASCULAR SEALING SYSTEM FDA PMA
- Generic Name
- Device, hemostasis, vascular FDA PMA
Identifiers
- PMA Number
- P150022 FDA PMA
- FDA Product Code
- MGB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Closer Vascular Sealing System (VSS) is a Device, Hemostasis, Vascular designed for percutaneous closure of femoral artery access sites. It employs a mechanical sealing mechanism to achieve hemostasis, reducing time to hemostasis and ambulation compared to traditional methods in patients undergoing diagnostic or interventional endovascular procedures with 5, 6, and 7 French procedural sheaths.
The system is supplied as a sterile, single-use device and is intended for use in vascular interventional settings. It is classified as a Class III medical device under FDA regulations and holds FDA_PMA authorization (PMA Number: P150022). Compliance with sterility and procedural requirements ensures safe use in clinical environments, with no noted MRI safety restrictions. The device is packaged for immediate clinical application and adheres to regulatory standards for vascular closure solutions.
Frequently asked questions
What types of vascular procedures is the Closer Vascular Sealing System designed to assist with, and what sheath sizes does it support?
The Closer Vascular Sealing System (VSS) is specifically designed for percutaneous closure of femoral artery access sites in patients undergoing diagnostic or interventional endovascular procedures. It is intended to reduce time to hemostasis and ambulation compared to traditional methods. The system is compatible with 5, 6, and 7 French procedural sheaths, making it suitable for a range of vascular interventions.
Is the Closer Vascular Sealing System reusable or single-use, and how is it packaged for clinical use?
The Closer Vascular Sealing System is supplied as a sterile, single-use device, ensuring safety and compliance with clinical standards. It is packaged for immediate clinical application, meaning no additional preparation is required before use.
What regulatory pathway has the Closer Vascular Sealing System followed, and what does this mean for its use in clinical settings?
The Closer Vascular Sealing System has undergone FDA Premarket Approval (PMA) with the PMA number P150022. This means the device has been thoroughly evaluated for safety and effectiveness by the FDA and is classified as a Class III medical device, which is the highest regulatory classification for medical devices requiring strict scrutiny due to its potential risks.
Are there any special considerations for storage or handling of the Closer Vascular Sealing System before use?
The Closer Vascular Sealing System is packaged for immediate clinical application, implying it is ready for use right out of the box. While specific storage instructions are not detailed in the provided data, adherence to standard sterile medical device storage practices—such as protecting it from contamination and extreme temperatures—is recommended to maintain its sterility and functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P150022 | Class III | Active |
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Manufacturer
- Manufacturer
- Rex Medical, L.P.
Sources (1)
- FDA PMA P150022 24 fields · synced Sep 18, 2026