FDA 510(k) Application Details - K010169

Device Classification Name Catheter, Percutaneous

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510(K) Number K010169
Device Name Catheter, Percutaneous
Applicant C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON, GA 30014-6421 US
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Contact CAROL VIERLING
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 01/18/2001
Decision Date 02/13/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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