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submarine plus percutaneous transluminal angioplasty pta catheter model suvxxxxxxxxx
Invatec Innovative Technologies
Summary: The Submarine Plus PTA Catheter is a device used for percutaneous transluminal angioplasty, primarily in venous interventions. It is utilized by interventional radiologists and vascular surgeons to improve blood flow in patients with vascular diseases.
FDA Clearance Information
Pathway
510K
Number
K042537 ↗
Decision Date
November 8, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Submarine Plus PTA Catheter by Invatec Innovative Technologies was cleared through the FDA 510(k) pathway on November 8, 2004. It is classified as a Class 2 device under product code DQY.
What It Is
The Submarine Plus PTA Catheter is a medical device designed for percutaneous transluminal angioplasty (PTA), a minimally invasive procedure to open up blocked or narrowed blood vessels. The catheter is inserted into the vascular system and guided to the site of stenosis, where a balloon is inflated to widen the vessel. This device is particularly useful in treating peripheral vascular diseases and enhancing blood flow in affected areas.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral artery disease (PAD) and other vascular conditions that cause narrowing of the blood vessels. Interventional radiologists and vascular surgeons typically employ this device in hospital settings or outpatient surgical centers. It is suitable for patients with conditions such as chronic venous insufficiency or those requiring revascularization of peripheral arteries.
Indications for Use
The FDA indications for the Submarine Plus PTA Catheter involve its use in percutaneous transluminal angioplasty procedures to treat narrowed or blocked blood vessels. It is intended for patients with vascular diseases that impair blood flow, such as those affecting the peripheral arteries.
Practical Considerations
The Submarine Plus PTA Catheter comes in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and introducer sheaths. Clinicians should be skilled in catheter-based interventions and aware of the specific technique for balloon inflation and deflation during angioplasty.
Frequently Asked Questions
What is the Submarine Plus PTA Catheter used for?
It is used for percutaneous transluminal angioplasty to open narrowed or blocked blood vessels and improve blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in percutaneous transluminal angioplasty procedures to treat narrowed or blocked blood vessels.
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.