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

FDA 510(k) Premarket Notification · Submission K252417 · Applicant: ABBOTT MEDICAL

Public Record 510(k) Submission Decision Date: 2025-12-17 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K252417.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K252417
Applicant / Sponsor
Device Name
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
Product Code
DQY
Decision Date
2025-12-17
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Cardiovascular (CV)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2025-08-01

Related Establishments / Registrations

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