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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K250031
Device Name Amplatzer Guidewire
Applicant
ABBOTT MEDICAL
177 County Rd. B E.
St. Paul,  MN  55117
Applicant Contact Dan Gapp
Correspondent
ABBOTT MEDICAL
177 County Rd. B E.
St. Paul,  MN  55117
Correspondent Contact Dan Gapp
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/07/2025
Decision Date 10/03/2025
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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