FDA 510(k)

Amplatzer Piccolo Delivery System (9-PDS-04F-045)

K-Number: K252417 · 2025-12-17

Decision Date2025-12-17

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Amplatzer Piccolo Delivery System (9-PDS-04F-045) is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-12-17 under approval number K252417. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Amplatzer Piccolo Delivery System (9-PDS-04F-045)?

Amplatzer Piccolo Delivery System (9-PDS-04F-045) is a medical device that received FDA 510(k) clearance on 2025-12-17. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K252417.

When was Amplatzer Piccolo Delivery System (9-PDS-04F-045) approved by the FDA?

Amplatzer Piccolo Delivery System (9-PDS-04F-045) received FDA 510(k) clearance on 2025-12-17, under approval number K252417.

What company makes Amplatzer Piccolo Delivery System (9-PDS-04F-045)?

Amplatzer Piccolo Delivery System (9-PDS-04F-045) is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Amplatzer Piccolo Delivery System (9-PDS-04F-045)?

The FDA product code for Amplatzer Piccolo Delivery System (9-PDS-04F-045) is DQY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.