Identity
- Trade Name
- QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM) FDA PMA
- Generic Name
- Device, hemostasis, vascular FDA PMA
Identifiers
- PMA Number
- P080029 FDA PMA
- FDA Product Code
- MGB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Quick-Close Vascular Suturing System is a Class III vascular hemostasis device designed to close femoral artery access sites. It employs a mechanical suturing mechanism to achieve rapid hemostasis, reducing bleeding time and enabling earlier patient ambulation following endovascular procedures.
This system is intended for single-use with 5, 6, 7, or 8 French procedural sheaths and is approved under FDA Premarket Approval (PMA P080029). It is supplied sterile and is not MRI-compatible. Storage and handling must comply with sterile medical device protocols to maintain integrity and functionality.
Frequently asked questions
What is the Quick-Close Vascular Suturing System designed to do in clinical procedures?
The Quick-Close Vascular Suturing System is specifically designed to close femoral artery access sites after endovascular procedures. It uses a mechanical suturing mechanism to achieve rapid hemostasis, which helps reduce bleeding time and allows patients to begin ambulating sooner. This is particularly useful for patients who have undergone diagnostic or interventional procedures using 5, 6, 7, or 8 French procedural sheaths, including those who received glycoprotein IIb/IIIa inhibitor therapy during the procedure.
Is the Quick-Close Vascular Suturing System intended for reuse, or is it meant for single-use only?
The Quick-Close Vascular Suturing System is explicitly intended for **single-use only**. This is a critical design feature to ensure patient safety, sterility, and device functionality. Reuse is not recommended or supported by the manufacturer.
What sheath sizes is the Quick-Close Vascular Suturing System compatible with, and how does this affect its use?
The system is compatible with **5, 6, 7, and 8 French procedural sheaths**, making it versatile for a range of endovascular procedures. This compatibility ensures it can be used across different patient sizes and procedural requirements, though the specific sheath size must match the patient’s access site to achieve proper hemostasis.
How should the Quick-Close Vascular Suturing System be stored, and why is this important?
The Quick-Close Vascular Suturing System is supplied **sterile**, so storage must comply with standard sterile medical device protocols. This includes protecting it from contamination, moisture, and physical damage to maintain its integrity and functionality before use. Improper storage could compromise sterility or device performance, risking patient safety.
Can the Quick-Close Vascular Suturing System be used in MRI environments, and if not, what are the implications?
No, the Quick-Close Vascular Suturing System is **not MRI-compatible**. This means it should not be used in or near MRI machines, as exposure to magnetic fields could affect its mechanical components or lead to unsafe conditions. Clinicians must ensure the device is removed from the patient before MRI imaging if needed.
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. Sources consulted: QUICK-CLOSE VASCULAR SUTURING SYSTEM 510 (k) FDA Approval, Quick-close Vascular Suturing System (Quick-close System) (P080029 ..., Quick-close Vascular Suturing System (Quick-close System), QUICK-CLOSE VASCULAR SUTURING SYSTEM Trademark - Registration Number ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P080029 | Class III | Active |
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Manufacturer
- Manufacturer
- Cardiva Medical, Inc.
Sources (1)
- FDA PMA P080029 24 fields · synced Sep 18, 2026