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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K103153
Device Name VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER
Applicant
Abbott Vascular-Cardiac Therapies
26531 Ynez Rd.
Mailing P.O. Box 9018
Temecula,  CA  92589 -9018
Applicant Contact SUZANNE REDMAN
Correspondent
Abbott Vascular-Cardiac Therapies
26531 Ynez Rd.
Mailing P.O. Box 9018
Temecula,  CA  92589 -9018
Correspondent Contact SUZANNE REDMAN
Regulation Number870.5100
Classification Product Code
LOX  
Date Received10/14/2010
Decision Date 12/30/2010
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
Recalls CDRH Recalls
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