Identity
- Trade Name
- Tack Endovascular System (6F) FDA PMA
- Generic Name
- Scaffold, dissection repair FDA PMA
Identifiers
- PMA Number
- P180034 FDA PMA
- FDA Product Code
- QCT FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Tack Endovascular System 6F is a dissection repair scaffold designed to address complications following vascular procedures. It is indicated for the repair of post percutaneous transluminal balloon angioplasty dissections in the superficial femoral and proximal popliteal arteries.
This device is intended for use in vessels ranging in diameter from 3.5mm to 6.0mm. The system is manufactured by Philips Image Guided Therapy Corporation and has received FDA PMA authorization for its clinical application. It is categorized under the cardiovascular medical specialty.
Frequently asked questions
What is the primary purpose of the Tack Endovascular System 6F?
The system acts as a dissection repair scaffold used to treat dissections that occur after percutaneous transluminal balloon angioplasty procedures.
Which blood vessels is this device designed to treat?
The Tack Endovascular System 6F is specifically indicated for use in the superficial femoral and proximal popliteal arteries.
What vessel diameter range is compatible with this system?
This device is designed for use in arteries that measure between 3.5mm and 6.0mm in diameter.
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 | P180034 | Class III | Active |
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Manufacturer
- Manufacturer
- Philips Image Guided Therapy Corporation
Sources (1)
- FDA PMA P180034 24 fields · synced Oct 6, 2026