📋 FDA Reference
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 ?
510(k)
Number ?
K252417 ↗
Decision Date ?
December 17, 2025
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used to deliver a compatible cardiovascular device or implant through the vasculature during a percutaneous procedure, as specified in the applicable device labeling.
- Intended for use by trained healthcare professionals in catheter-based cardiovascular procedures.
Clinical Applications
- Percutaneous delivery and positioning of a compatible cardiovascular implant.
- Catheter-based procedures in which controlled advancement and deployment of an implant are required.
- Use in appropriately selected pediatric or adult patients when the compatible implant and delivery-system labeling permit it.
Practical Considerations
- The 9-PDS-04F-045 designation identifies a 4 French delivery-system configuration; compatibility must be confirmed against the specific implant and the current Abbott instructions for use.
- The system is advanced through vascular access under imaging guidance, typically fluoroscopy, and should be handled by clinicians trained in catheter-based cardiovascular procedures.
- Patient anatomy, access-vessel size, implant dimensions, and the required delivery route must be assessed before use.
- MRI safety depends on the delivered implant and any retained components, not only on the delivery catheter. Follow the current device labeling and MR-conditional conditions.
- Contraindications, warnings, and handling requirements should be taken from the current manufacturer labeling; the FDA record supplied here does not provide a complete contraindication list.
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.