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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 K914581
Device Name HEART TECHNOLOGY WIRECLIP
Applicant
Heart Technology, Inc.
2515 140th Ave. NE
Bellevue,  WA  98005
Applicant Contact LOUISE MYERS
Correspondent
Heart Technology, Inc.
2515 140th Ave. NE
Bellevue,  WA  98005
Correspondent Contact LOUISE MYERS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/16/1991
Decision Date 01/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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