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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K000101
Device Name RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054 -2807
Applicant Contact KOBBY DANKWAH
Correspondent
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054 -2807
Correspondent Contact KOBBY DANKWAH
Regulation Number870.1250
Classification Product Code
LIT  
Date Received01/13/2000
Decision Date 02/10/2000
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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