FDA 510(k) Application Details - K023320

Device Classification Name Catheter, Percutaneous

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510(K) Number K023320
Device Name Catheter, Percutaneous
Applicant GUIDANT CORP.
1525 O'BRIEN DR.
MENLO PARK, CA 94025 US
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Contact MICHELLE GROSSMAN
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 10/04/2002
Decision Date 12/10/2002
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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