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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K252042
Device Name Sync AV II Temporary Pacing Catheter
Applicant
Swift Sync, Inc.
455 NE 91st St.
Miami Shores,  FL  33138
Applicant Contact Christian Marin y Kall
Correspondent
RQM+
5000 Centregreen Way
Suite 100
Cary,  NC  27513
Correspondent Contact Hrishikesh Gadagkar
Regulation Number870.3680
Classification Product Code
LDF  
Date Received06/30/2025
Decision Date 07/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT06261788
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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