# K252417: Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Dec 17, 2025 after 138 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K893658 (1989). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162228: TorqVue Low Profile Delivery Catheter, Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor (2016) Summary page 5.

## Indications for use
The Amplatzer Piccolo™ Delivery System is indicated to facilitate the delivery of an Amplatzer Piccolo™ Occluder through the heart of a patient with a patent ductus arteriosus.

Source page: https://510kreport.com/device/K252417
Methodology: https://510kreport.com/methodology