ACS RX Gemini Coronary Dilatation Catheter
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE FDA PMA
- Generic Name
- Catheters, transluminal coronary angioplasty, percutaneous FDA PMA
Identifiers
- PMA Number
- P810046 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
- APPR Approved FDA PMA
- PMA Supplement
- S007 FDA PMA
The ACS RX Gemini Coronary Dilatation Catheter is a percutaneous transluminal coronary angioplasty catheter, designed to mechanically widen narrowed or obstructed coronary arteries. It employs an inflatable balloon at its distal tip to dilate atherosclerotic lesions, restoring blood flow and improving myocardial perfusion in patients with coronary artery disease.
This catheter is supplied as a single-use, non-sterile device intended for use in interventional cardiology procedures within a sterile field. It is classified under FDA regulation 870.5100 and has received FDA Premarket Approval (PMA) under PMA number P810046. The device is compatible with standard angiographic imaging systems and is not intended for use in MRI environments. Proper storage and handling per manufacturer instructions are required to maintain device integrity.
Frequently asked questions
What is the primary clinical purpose of the ACS RX Gemini Coronary Dilatation Catheter, and how does it achieve this?
The ACS RX Gemini Coronary Dilatation Catheter is designed to mechanically widen narrowed or obstructed coronary arteries through percutaneous transluminal coronary angioplasty (PTCA). It achieves this by inflating a balloon at its distal tip, which compresses atherosclerotic plaque against the arterial wall, thereby restoring blood flow and improving myocardial perfusion in patients with coronary artery disease.
Is the ACS RX Gemini Coronary Dilatation Catheter intended for single-use or repeated use, and what does this mean for its sterility?
The device is explicitly labeled as a single-use catheter and is supplied in a non-sterile state. This means it must be used once per patient and then discarded. Sterilization must be performed within a sterile field during the procedure, as the catheter itself is not pre-sterilized for direct patient use.
What regulatory pathway was followed for FDA clearance of this device, and what does this indicate about its approval status?
The ACS RX Gemini Coronary Dilatation Catheter received FDA Premarket Approval (PMA) under PMA number P810046, which is the highest level of regulatory review for medical devices in the U.S. This indicates that the device underwent rigorous clinical trials and scientific evaluation to demonstrate safety and effectiveness before approval.
Can this catheter be used with standard angiographic imaging systems, and are there any environmental restrictions on its use?
Yes, the ACS RX Gemini Coronary Dilatation Catheter is explicitly designed to be compatible with standard angiographic imaging systems. However, it is not intended for use in MRI environments, as the device may interfere with magnetic resonance imaging or pose safety risks in such settings.
What storage and handling instructions should be followed to ensure the device remains intact before use?
The manufacturer specifies that proper storage and handling per their instructions are required to maintain device integrity. While exact storage conditions (e.g., temperature, humidity) are not detailed in the provided data, adherence to the manufacturer’s guidelines—such as avoiding contamination, physical damage, or improper packaging—is critical to ensure the catheter performs as intended during the procedure.
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 | P810046 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Cardiovascular Systems, Inc.
Sources (1)
- FDA PMA P810046 24 fields · synced Sep 18, 2026