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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 K243436
Device Name Seclusion Catheter
Applicant
Basis Medical
4080 Mcginnis Ferry Rd., Bldg. 300, Suite 304
Alpharetta,  GA  30005
Applicant Contact David Martin
Correspondent
Powers Regulatory Consulting
2451 Cumberland Blvd. SE
Suite 3740
Atlanta,  GA  30339
Correspondent Contact Grace Powers
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/05/2024
Decision Date 02/28/2025
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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