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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K031505
Device Name RAPIDO CUT-AWAY GUIDING CATHETER
Applicant
Guidant Corporation
4100 Hamline Ave., N.
St. Paul,  MN  55112 -5798
Applicant Contact SHAH M HILALI
Correspondent
Guidant Corporation
4100 Hamline Ave., N.
St. Paul,  MN  55112 -5798
Correspondent Contact SHAH M HILALI
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/14/2003
Decision Date 06/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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