Cleared Traditional

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

K252417 · Abbott Medical · Cardiovascular
Dec 2025
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K252417 is an FDA 510(k) clearance for the Amplatzer Piccolo? Delivery System (9-PDS-04F-045), 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 review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K252417 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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