Amplatzer Piccolo Delivery System (9-PDS-04F-045)
FDA 510(k) K252417 · Abbott Medical
510(k) numberK252417
Submission
- Device name
- Amplatzer Piccolo Delivery System (9-PDS-04F-045)
- Applicant
- Abbott Medical
St. Paul, MN, US - Received
- August 1, 2025
- Decision date
- December 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Amplatzer Piccolo Delivery System (9-PDS-04F-045) cleared by the FDA?
Amplatzer Piccolo Delivery System (9-PDS-04F-045) (K252417) received a 510(k) decision of Substantially Equivalent on December 17, 2025, 138 days after the submission was received.
What is the product code of K252417?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.