Identity
- Trade Name
- VASCADE VASCULAR CLOSURE SYSTEM FDA PMA
- Generic Name
- Device, hemostasis, vascular FDA PMA
Identifiers
- PMA Number
- P120016 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 VASCADE Vascular Closure System is a device indicated for femoral arterial access site closure while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures using a 5F, 6F, or 7F procedural sheath. It is also indicated to reduce time to discharge eligibility in patients who have undergone diagnostic endovascular procedures using a 5F, 6F, or 7F procedural sheath.
Supplied as a sterile, single-use system, the VASCADE VCS is used in clinical settings following endovascular interventions. It is authorized under FDA PMA (P120016) and classified as a Class III device for vascular hemostasis. No MRI safety information or specific storage conditions are provided in the data.
Frequently asked questions
What procedural sheath sizes is the VASCADE Vascular Closure System compatible with?
The VASCADE Vascular Closure System is indicated for use with 5F, 6F, or 7F procedural sheaths, as stated in the device's approval documentation for both diagnostic and interventional endovascular procedures.
Is the VASCADE Vascular Closure System reusable or single-use?
The VASCADE Vascular Closure System is supplied as a sterile, single-use system, meaning it is intended for one-time use only and should not be reprocessed or reused.
What regulatory authorization does the VASCADE Vascular Closure System have?
The VASCADE Vascular Closure System has received FDA Premarket Approval (PMA) under number P120016, as indicated in the AUTHORIZATIONS field of the device data.
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 | P120016 | Class III | Active |
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Manufacturer
- Manufacturer
- Cardiva Medical, Inc.
Sources (1)
- FDA PMA P120016 24 fields · synced Sep 18, 2026