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amplatzer piccolo delivery system 9-pds-04f-045
Abbott Medical
Summary: The Amplatzer Piccolo Delivery System is a medical device used for delivering venous stents, primarily in pediatric and adult cardiology. It is utilized by interventional cardiologists to treat specific heart conditions.
FDA Clearance Information
Pathway
510K
Number
K252417 ↗
Decision Date
December 17, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer Piccolo Delivery System, manufactured by Abbott Medical, received FDA clearance via the 510k pathway on December 17, 2025. It is classified as a Class 2 device under product code DQY.
What It Is
The Amplatzer Piccolo Delivery System is a specialized catheter-based device designed to deliver venous stents to targeted areas within the cardiovascular system. It is engineered to navigate through the vascular system and accurately place stents, which help maintain vessel patency. The device is particularly useful in procedures requiring precision and control, such as in pediatric patients with congenital heart defects.
Clinical Applications
This device is commonly used in interventional cardiology, particularly in procedures involving the placement of venous stents in patients with congenital or acquired heart conditions. It is suitable for use in both pediatric and adult populations, often in a hospital or specialized cardiac care setting. The device aids in the treatment of conditions like patent ductus arteriosus (PDA) and other structural heart issues.
Indications for Use
The FDA-cleared indications for the Amplatzer Piccolo Delivery System include the delivery of venous stents in patients with specific cardiovascular conditions. It is intended for use in patients who require stent placement to support blood flow and vessel integrity.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard catheterization techniques and should be used by trained interventional cardiologists. Proper sizing and placement are crucial for optimal outcomes.
Frequently Asked Questions
What is Amplatzer Piccolo Delivery System used for?
It is used for delivering venous stents in patients with cardiovascular conditions, particularly in pediatric and adult cardiology.
What specialties typically use this device?
Interventional cardiologists, especially those focusing on pediatric and adult congenital heart disease, typically use this device.
What are the FDA-cleared indications?
The device is indicated for the delivery of venous stents in patients needing vascular support for specific heart conditions.
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.