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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K252417
Device Name Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
Applicant
Abbott Medical
177 County Rd. B E.
St.Paul,  MN  55117
Applicant Contact Nicolette Pedersen
Correspondent
Abbott Medical
177 County Rd. B E.
St.Paul,  MN  55117
Correspondent Contact Nicolette Pedersen
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/01/2025
Decision Date 12/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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