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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 K042388
Device Name RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
Applicant
Radiant Medical
250 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact ANDREW CLEELAND
Correspondent
Radiant Medical
250 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact ANDREW CLEELAND
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/02/2004
Decision Date 10/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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