Identity
- Trade Name
- FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER FDA PMA
- Generic Name
- Catheters, transluminal coronary angioplasty, percutaneous FDA PMA
Identifiers
- PMA Number
- P020037 FDA PMA
- FDA Product Code
- LOX FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 870.5100 FDA PMA
- Regulation Number
- 870.5100 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APRL FDA PMA
The FX Minirail RX PTCA Catheter is a catheter, transluminal coronary angioplasty, percutaneous, designed for balloon dilation of stenotic coronary arteries, including in-stent restenosis. It improves myocardial perfusion by mechanically widening narrowed arterial segments through controlled inflation of its integrated balloon.
This device is supplied as a single-use, non-sterile catheter intended for use in interventional cardiology procedures. It is regulated under the FDA PMA (Premarket Approval) pathway and falls under Device Class II (regulation number 870.5100). The catheter is engineered for precise placement via femoral or radial access and requires sterile preparation prior to use in a clinical setting.
Frequently asked questions
What is the FX Minirail RX PTCA Catheter primarily used for in clinical practice?
The FX Minirail RX PTCA Catheter is designed for balloon dilation of stenotic (narrowed) coronary arteries, including cases of in-stent restenosis. Its purpose is to mechanically widen narrowed arterial segments to improve myocardial perfusion during interventional cardiology procedures.
Is this device intended for single-use or repeated use in a clinical setting?
The FX Minirail RX PTCA Catheter is explicitly supplied as a single-use device. It is non-sterile at the time of shipment and must be sterilized prior to use in a clinical environment, as required for interventional procedures.
How is the FX Minirail RX PTCA Catheter accessed during a procedure, and what access points does it support?
The catheter is engineered for precise placement via femoral or radial access, allowing flexibility in procedural approach depending on patient anatomy and clinical preference.
What regulatory pathway does the FX Minirail RX PTCA Catheter follow, and what class does it belong to?
The device is regulated under the FDA PMA (Premarket Approval) pathway and is classified as a Class II medical device under regulation number 870.5100. This pathway ensures rigorous evaluation of its safety and effectiveness for balloon dilation of coronary arteries.
What steps must be taken to prepare the FX Minirail RX PTCA Catheter for use in a procedure?
Since the catheter is supplied non-sterile, it must undergo sterile preparation prior to use in a clinical setting. This ensures compliance with interventional cardiology standards and patient safety before deployment.
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 | P020037 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular Inc.
- FDA Applicant
- Abbott Vascular, Inc.
Sources (1)
- FDA PMA P020037 24 fields · synced Sep 18, 2026