FDA 510(k) Application Details - K024327

Device Classification Name Catheter, Percutaneous

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510(K) Number K024327
Device Name Catheter, Percutaneous
Applicant RADIANT MEDICAL
250 CHESAPEAKE DR.
REDWOOD CITY, CA 94063 US
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Contact ANDREW CLEELAND
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 12/26/2002
Decision Date 03/25/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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