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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 K002346
Device Name WIRE, GUIDE, CATHETER, MODEL QSW1000
Applicant
MEDTRONIC AVE, INC.
1660 WAYZATA BLVD.
MINNETONKA,  MN  55305
Applicant Contact LINDA (LINN) LAAK
Correspondent
MEDTRONIC AVE, INC.
1660 WAYZATA BLVD.
MINNETONKA,  MN  55305
Correspondent Contact LINDA (LINN) LAAK
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/02/2000
Decision Date 09/27/2000
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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