K252417 is an FDA 510(k) clearance for the Amplatzer Piccolo™ Delivery System (9-PDS-04F-045). This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Abbott Medical (St. Paul, US). The FDA issued a Cleared decision on December 17, 2025, 138 days after receiving the submission on August 1, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K252417 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2025 |
| Decision Date | December 17, 2025 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |