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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 Avenue North
St. Paul,  MN  55112 -5798
Applicant Contact SHAH HILALI
Correspondent
GUIDANT CORP.
4100 Hamline Avenue North
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
Recalls CDRH Recalls
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