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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 K983346
Device Name STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF
Applicant
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054 -2807
Applicant Contact MARGARET ANDERSON
Correspondent
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054 -2807
Correspondent Contact MARGARET ANDERSON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/23/1998
Decision Date 03/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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