FDA 510(k) Application Details - K003880

Device Classification Name Catheter, Percutaneous

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510(K) Number K003880
Device Name Catheter, Percutaneous
Applicant CONCENTRIC MEDICAL, INC.
2585 LEGHORN ST.
MOUTIAN VIEW, CA 94043 US
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Contact SAM LAZZARA
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 12/15/2000
Decision Date 05/16/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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