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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 K921311
Device Name CORDIS SHUTTLE CATHETER W/ SIDEHOLES
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact TAMARA HARDER
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact TAMARA HARDER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/18/1992
Decision Date 09/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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