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passeo-35 pta catheter
Biotronik
Summary: The Passeo-35 PTA Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to treat peripheral vascular diseases. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K082933 ↗
Decision Date
November 3, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Passeo-35 PTA Catheter was cleared through the FDA 510(k) pathway on November 3, 2008. Manufactured by Biotronik, it is classified as a Class 2 device under product code DQY.
What It Is
The Passeo-35 PTA Catheter is a balloon catheter designed for percutaneous transluminal angioplasty, a procedure to open narrowed or blocked blood vessels. The device consists of a flexible catheter with an inflatable balloon at its tip, which is used to dilate the vessel and restore blood flow. It is typically utilized in the treatment of peripheral arterial disease (PAD) in the lower extremities.
Clinical Applications
The Passeo-35 PTA Catheter is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat patients with peripheral arterial disease, particularly those with stenotic or occlusive lesions in the iliac, femoral, or popliteal arteries. This device is suitable for use in hospitals and outpatient centers where endovascular interventions are performed.
Indications for Use
The FDA indications for the Passeo-35 PTA Catheter include its use in dilating stenotic segments of peripheral arteries. It is intended for patients with peripheral vascular disease who require intervention to improve blood flow and alleviate symptoms such as claudication.
Practical Considerations
The Passeo-35 PTA Catheter is available in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with angioplasty techniques and consider vessel characteristics when selecting balloon size.
Related Literature
The linked study titled 'BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions' investigates the use of a stent in conjunction with the Passeo-35 PTA Catheter for treating iliac artery lesions. Although the abstract is not available, the study likely evaluates the efficacy and safety of the stent in improving vessel patency. Limitations may include a lack of long-term follow-up data.
Frequently Asked Questions
What is Passeo-35 PTA Catheter used for?
The Passeo-35 PTA Catheter is used for percutaneous transluminal angioplasty to treat narrowed or blocked peripheral arteries.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Passeo-35 PTA Catheter.
What are the FDA-cleared indications?
The device is indicated for dilating stenotic segments of peripheral arteries in patients with peripheral vascular disease.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.