Amphirion Plus PTA Catheter
510(k) K121265
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121265 | Date22 May 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LIT
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Amphirion Plus PTA Catheter is a percutaneous transluminal angioplasty catheter designed for peripheral vascular interventions. It is classified as an over-the-wire device featuring a coaxial shaft with a distal dilatation balloon, enabling controlled dilation of arterial stenosis or occlusions in peripheral arteries. The device includes two lumens: one for guidewire passage (compatible with 0.014" guidewires) and another for balloon inflation and deflation, supported by radiopaque marker bands for precise positioning under fluoroscopy.
This catheter is intended for single-use in clinical settings such as catheterization labs or angiography suites. Supplied sterile, it is regulated under FDA 510(k) clearance (K121265) as a Class II device (regulation number 870.1250) and is non-magnetic, ensuring compatibility with MRI environments. Available in multiple reference codes and sizes, it requires proper storage in a clean, dry environment to maintain sterility and functionality. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the device data.
Other devices from Medtronic, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of peripheral vascular procedures is the Amphirion Plus PTA Catheter designed for?
The Amphirion Plus PTA Catheter is specifically designed for percutaneous transluminal angioplasty (PTA) procedures to dilate arterial stenosis or occlusions in peripheral arteries. Its over-the-wire design with a coaxial shaft and distal balloon allows controlled dilation, making it suitable for interventions in catheterization labs or angiography suites where precise positioning under fluoroscopy is required.
Is the Amphirion Plus PTA Catheter compatible with MRI environments, and why?
Yes, the Amphirion Plus PTA Catheter is non-magnetic, which means it is safe to use in MRI environments. This feature ensures that the device will not be affected by magnetic fields, reducing the risk of displacement or interference during imaging or procedures.
How should the Amphirion Plus PTA Catheter be stored to maintain its sterility and functionality?
The device must be stored in a clean, dry environment to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, proper storage conditions are critical to prevent contamination and ensure the device remains ready for immediate clinical use.
What guidewire compatibility does the Amphirion Plus PTA Catheter support, and how does this affect its use?
The Amphirion Plus PTA Catheter is designed to accommodate 0.014-inch guidewires, allowing flexibility in procedural planning. This compatibility ensures that clinicians can use their preferred guidewire while maintaining the catheter’s ability to navigate and dilate peripheral arteries effectively.
Are there multiple sizes or models available for the Amphirion Plus PTA Catheter, and how does this benefit clinicians?
Yes, the Amphirion Plus PTA Catheter is available in multiple reference codes and sizes, as indicated by the extensive list of FEI numbers. This variety allows clinicians to select the appropriate catheter length and diameter for different anatomical locations and procedural requirements, enhancing versatility and precision in peripheral vascular interventions.