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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K003398
Device Name WIRECLIP TORQUER
Applicant
Boston Scientific Corporation Northwest Technology
17425 NE Union Hill Rd.
Redmond,  WA  98052
Applicant Contact JOCELYN KERSTEN
Correspondent
Boston Scientific Corporation Northwest Technology
17425 NE Union Hill Rd.
Redmond,  WA  98052
Correspondent Contact JOCELYN KERSTEN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/01/2000
Decision Date 12/01/2000
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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