FDA 510(k) Application Details - K973298

Device Classification Name Catheter, Percutaneous

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510(K) Number K973298
Device Name Catheter, Percutaneous
Applicant CARDIMA, INC.
47266 BENICIA ST.
FREMONT, CA 94538-1372 US
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Contact SHELLEY TRIMM
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 09/02/1997
Decision Date 06/26/1998
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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