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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 K243184
Device Name SAT CenterFlow Molding Balloon Catheter (IN20-00313)
Applicant
Strait Access Technologies Holdings
313 Chris Barnard Bldg., Anzio Rd.
Observatory 7925
Cape Town,  ZA
Applicant Contact Malcolm Applewhite
Correspondent
Medical Device Academy
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Robert Packard
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/30/2024
Decision Date 06/25/2025
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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