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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K251211
Device Name ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™
Applicant
Abbott Medical
5050 Nathan Lane N.
Plymouth, Mn,  MN  55442
Applicant Contact Adam Bakken
Correspondent
Abbott Medical
5050 Nathan Lane N.
Plymouth, Mn,  MN  55442
Correspondent Contact Adam Bakken
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Codes
DYB   MTD   OWQ  
Date Received04/18/2025
Decision Date 05/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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