Angio-Seal Vascular Closure Device STS Plus Platform
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Angio Seal Vascular Closure Device FDA PMA
- Generic Name
- Device, hemostasis, vascular FDA PMA
Identifiers
- PMA Number
- P930038 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 Angio-Seal Vascular Closure Device STS Plus Platform is a Device, Hemostasis, Vascular designed for achieving hemostasis at arterial puncture sites. It employs a collagen plug and synthetic suture to seal vascular access points, reducing bleeding risk during and after procedures such as angiography or catheterization. This device is intended for use in percutaneous interventions where rapid and reliable vascular closure is critical.
The device is supplied sterile and intended for single-use in clinical settings such as catheterization labs or interventional radiology suites. It is classified as a Class III medical device under FDA regulations and requires FDA_PMA authorization. The STS Plus Platform is available in various sizes to accommodate different sheath diameters, ensuring compatibility with standard vascular access procedures. Storage and handling must adhere to sterile field protocols to maintain device integrity.
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 | P930038 | Class III | Active |
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Manufacturer
- Manufacturer
- Terumo Medical Corporation
Sources (1)
- FDA PMA P930038 24 fields · synced Oct 6, 2026