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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K241115
Device Name SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
Applicant
Spectrum Vascular
50 Main St.
Suite 1000
White Plains,  NY  10606
Applicant Contact Sharon Klugewicz
Correspondent
Spectrum Vascular
50 Main St.
Suite 1000
White Plains,  NY  10606
Correspondent Contact Sharon Klugewicz
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/23/2024
Decision Date 11/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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