Identity
- Trade Name
- CELT ACD VASCULAR CLOSURE DEVICE FDA PMA
- Generic Name
- Device, hemostasis, vascular FDA PMA
Identifiers
- PMA Number
- P150006 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 CELT ACD Vascular Closure Device is a vascular hemostasis device indicated for the percutaneous closure of common femoral artery puncture sites. It is designed to reduce time-to-hemostasis in patients who have undergone diagnostic or interventional intra-arterial catheterization procedures using 5F or 6F introducer sheaths.
Supplied by Vasorum, Ltd., this device is authorized under FDA PMA P150006. It is intended for use in clinical settings following catheterization procedures where arterial access was obtained via 5F or 6F sheaths, and it functions as a vascular closure solution to achieve hemostasis.
Frequently asked questions
What is the CELT ACD Vascular Closure Device used for?
The CELT ACD Vascular Closure Device is indicated for the percutaneous closure of common femoral artery puncture sites in patients who have undergone diagnostic or interventional intra-arterial catheterization procedures where either 5F or 6F introducer sheaths have been used, with the goal of reducing time-to-hemostasis.
Who manufactures the CELT ACD Vascular Closure Device?
The CELT ACD Vascular Closure Device is manufactured by Vasorum, Ltd., as stated in the device data under the applicant and manufacturer fields.
What regulatory authorization does the CELT ACD Vascular Closure Device have?
The device has received FDA PMA approval, as indicated by the AUTHORIZATIONS field showing FDA_PMA and the PMA number P150006 in the specifications.
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 | P150006 | Class III | Active |
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Manufacturer
- Manufacturer
- Vasorum, Ltd.
Sources (1)
- FDA PMA P150006 24 fields · synced Sep 18, 2026