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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 K241538
Device Name TriClip Steerable Guide Catheter
Applicant
Abbott Medical
177 County Rd. B E.
St.Paul,  MN  55117
Applicant Contact Irma Barr
Correspondent
Abbott Medical
177 County Rd. B E.
St.Paul,  MN  55117
Correspondent Contact Irma Barr
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/30/2024
Decision Date 08/26/2024
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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