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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biopsy, Endomyocardial
510(k) Number K000409
Device Name MODIFICATION TO T-REX BIOPSY FORCEPS
Applicant
Boston Scientific Corp
17425 N. E. Union Hill Rd.
Northwest Technology Center
Redmond,  WA  98052
Applicant Contact JOCELYN KERSTEN
Correspondent
Boston Scientific Corp
17425 N. E. Union Hill Rd.
Northwest Technology Center
Redmond,  WA  98052
Correspondent Contact JOCELYN KERSTEN
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received02/08/2000
Decision Date 02/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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