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This document provides the 510(k) summary for a modified PTA catheter developed by Angioslide Ltd., detailing device specifications, indications for use, and substantial equivalence to predicate devices.
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How to fill out proteustm pta balloon caformter
How to fill out PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature 510(k) Summary
01
Gather necessary materials, including the PROTEUSTM PTA Balloon Catheter and any additional equipment required for the procedure.
02
Prepare the catheter by removing it from its sterile packaging in a clean environment.
03
Ensure that the balloon is properly deflated before insertion.
04
Confirm that the embolic capture feature is functioning correctly according to the manufacturer's guidelines.
05
Insert the catheter into the appropriate access site using standard interventional techniques.
06
Navigate the catheter to the target site, using imaging guidance if necessary.
07
Inflate the balloon to the recommended pressure to achieve the desired dilation of the vessel.
08
Monitor the situation to ensure the embolic capture feature activates as intended during the procedure.
09
After the procedure, carefully withdraw the catheter while ensuring proper collection of any embolic material as per guidelines.
10
Dispose of the used catheter and related materials according to safety protocols.
Who needs PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature 510(k) Summary?
01
Healthcare professionals involved in interventional radiology or vascular surgery.
02
Patients who require treatment for vascular blockages.
03
Clinics and hospitals that perform endovascular procedures.
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People Also Ask about
What is the indication of a balloon catheter?
The Athletis PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature including upper extremity, renal, iliac, and infrainguinal vessels and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
What is balloon catheter description?
Balloon catheters are used for a range of medical procedures and applications, from delivering stents to opening blockages to dilating vessels to delivering therapeutics directly to a target location in the body.
What is the intended use of a balloon catheter?
Coronary balloon catheters are polymer, long tubes ended with a special balloon and are used during coronary angioplasty, i.e., widening of a narrowed artery (PCI, PTCA). The coronary arteries supply oxygen-rich blood to the heart muscle and thus ensure its proper function.
What is a PTA balloon catheter?
The Gateway TM PTA Balloon Catheter is an over-the-wire co-axial catheter with a balloon near the distal tip. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use ofguidewires (•< 0.014 in./0.36 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated.
What is the purpose of a balloon catheter?
A balloon catheter is a type of "soft" catheter with an inflatable "balloon" at its tip which is used during a catheterization procedure to enlarge a narrow opening or passage within the body.
What is a balloon dilation catheter used for?
A balloon dilation is a cardiac catheterization procedure, a small, flexible tube (catheter) is inserted into a blood vessel in the groin, and guided to the inside of the heart. The tube has a deflated balloon in the tip. When the tube is placed in the narrowed valve, the balloon is inflated to stretch the area open.
Where are balloon catheters used?
When narrowing occurs in the arteries that carry blood to and from the heart, it can cause serious conditions such as coronary artery disease and carotid artery disease. Balloon angioplasty is a minimally invasive cardiac catheterization procedure used to open narrow and blocked arteries.
What is percutaneous transluminal coronary angioplasty balloon dilatation catheter?
A balloon catheter is then guided to the blockage site. The balloon is inflated for a few seconds to compress the blockage against the artery wall. Then it's deflated. The doctor may inflate the balloon a few more times, each time filling it a little more to widen the passage.
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What is PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature 510(k) Summary?
The PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature 510(k) Summary is a document that provides a comprehensive overview of the device's design, intended use, performance, and safety information, submitted to the FDA for clearance.
Who is required to file PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature 510(k) Summary?
The manufacturer or an authorized representative of the manufacturer is required to file the PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature 510(k) Summary with the FDA.
How to fill out PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature 510(k) Summary?
To fill out the PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature 510(k) Summary, manufacturers must provide detailed information about the device, including its intended use, design characteristics, performance data, labeling, and any relevant testing results.
What is the purpose of PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature 510(k) Summary?
The purpose of the PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature 510(k) Summary is to demonstrate that the device is safe and effective for its intended use and is substantially equivalent to a legally marketed device.
What information must be reported on PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature 510(k) Summary?
The information that must be reported includes the device description, intended use, substantial equivalence rationale, clinical and non-clinical performance data, labeling practices, and any potential risks associated with the device.
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