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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K243642
Device Name UltraCor™ Twirl™ Breast Tissue Marker
Applicant
Bard Peripheral Vascular, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact Meghan McKelvey
Correspondent
Bard Peripheral Vascular, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact Meghan McKelvey
Regulation Number878.4300
Classification Product Code
NEU  
Date Received11/26/2024
Decision Date 03/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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