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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 K890959
Device Name GUIDEWIRE
Applicant
Guidewire Technologies, Inc.
10 Lawrence Rd.
Salem,  NH  03079
Applicant Contact DOUGLAS J CURTIS
Correspondent
Guidewire Technologies, Inc.
10 Lawrence Rd.
Salem,  NH  03079
Correspondent Contact DOUGLAS J CURTIS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/27/1989
Decision Date 09/12/1989
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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