FDA 510(k) Application Details - K111850

Device Classification Name Catheter, Percutaneous

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510(K) Number K111850
Device Name Catheter, Percutaneous
Applicant C.R. BARD, INC.
1625 WEST 3RD ST
TEMPE, AZ 85281 US
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Contact CANDACE WADE
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 06/29/2011
Decision Date 07/13/2011
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 Y
Expedited Review



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