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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 K031459
Device Name RAPIDO CUT-AWAY CUTTER
Applicant
Guidant Corp.
4100 Hamline Ave., N.
St. Paul,  MN  55112 -5798
Applicant Contact SHAH HILALI
Correspondent
Guidant Corp.
4100 Hamline Ave., N.
St. Paul,  MN  55112 -5798
Correspondent Contact SHAH HILALI
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/08/2003
Decision Date 07/23/2003
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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