K252417
- 510(k) number
- K252417
- Device name
- Amplatzer Piccolo Delivery System (9-PDS-04F-045)
- Applicant
- ABBOTT MEDICAL MN · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-12-17
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252417.pdf
Official FDA record: K252417
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.