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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
Recalls CDRH Recalls
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