Cross-Seal Suture-Mediated Vascular Closure Device System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Cross-Seal Suture-Mediated Vascular Closure Device System FDA PMA
- Generic Name
- Device, hemostasis, vascular FDA PMA
Identifiers
- PMA Number
- P210017 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 Cross-Seal Suture-Mediated Vascular Closure Device System is a Class III vascular hemostasis device designed for percutaneous closure of the common femoral artery access site. It employs suture-mediated technology to achieve hemostasis, reducing time-to-hemostasis in patients undergoing diagnostic or interventional catheterization procedures using 8F to 18F sheaths. The system is intended for use at a single access site per leg.
The device is supplied sterile and is intended for single-use. It is indicated for use in clinical settings where vascular access closure is required post-procedure. The system is regulated under an FDA Premarket Approval (PMA) with PMA number P210017, ensuring compliance with stringent safety and efficacy standards. No MRI safety information or reusable components are specified in the data.
Frequently asked questions
What is the primary purpose of the Cross-Seal Suture-Mediated Vascular Closure Device System, and how does it differ from traditional vascular closure methods?
The Cross-Seal System is designed specifically for percutaneous closure of the common femoral artery access site after diagnostic or interventional catheterization procedures using 8F to 18F sheaths. Unlike traditional manual compression or other closure devices, it uses suture-mediated technology to achieve hemostasis, which is intended to reduce the time required to stop bleeding post-procedure. This can be particularly beneficial in clinical settings where minimizing access site complications and patient recovery time are priorities.
Is the Cross-Seal System intended for use in both diagnostic and interventional procedures, and how many access sites per leg can it close?
Yes, the system is indicated for use in patients undergoing *both* diagnostic and interventional catheterization procedures. However, it is designed for a single access site per leg only, meaning one device is used per closure site in that leg. This limitation helps ensure proper sealing and reduce the risk of complications.
How is the Cross-Seal System supplied, and is it reusable or single-use?
The Cross-Seal System is supplied sterile and is explicitly intended for *single-use only*. This ensures patient safety by eliminating the risk of cross-contamination or degradation of performance from repeated use. Each device is packaged for one-time clinical application.
What regulatory pathway does the Cross-Seal System follow, and what does this mean for its use in clinical settings?
The Cross-Seal System is regulated under the FDA’s Premarket Approval (PMA) pathway, with PMA number **P210017**. This means it has undergone rigorous review to demonstrate safety and effectiveness, ensuring it meets stringent Class III device standards. Clinically, this approval indicates the device has been evaluated for its intended use—percutaneous closure of the common femoral artery access site—with a focus on reducing time-to-hemostasis in procedures using 8F to 18F sheaths.
Are there specific sheath sizes that the Cross-Seal System is compatible with, and how might this affect procedure planning?
The Cross-Seal System is compatible with sheath sizes ranging from **8F to 18F**, which covers a broad spectrum of diagnostic and interventional procedures. This versatility allows clinicians to use the system across various cases without needing alternative closure methods, provided the access site is the common femoral artery. When planning a procedure, confirming the sheath size beforehand ensures the system can be selected appropriately for optimal closure.
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 | P210017 | Class III | Active |
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Manufacturer
- Manufacturer
- Terumo Medical Corporation
Sources (1)
- FDA PMA P210017 23 fields · synced Oct 6, 2026