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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 K243224
Device Name MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)
Applicant
ABBOTT MEDICAL
177 County Rd. B E.
St. Paul,  MN  55117
Applicant Contact Vidya Thyagarajan
Correspondent
ABBOTT MEDICAL
177 County Rd. B E.
St. Paul,  MN  55117
Correspondent Contact Vidya Thyagarajan
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/07/2024
Decision Date 12/31/2024
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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