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FDA 510(k) Application Details - K061843
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K061843
Device Name
Catheter, Percutaneous
Applicant
ST. JUDE MEDICAL
6550 WEDGWOOD RD. NORTH
SUITE 150
MAPLE GROVE, MN 55311 US
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Contact
SHANNON SPRINGER
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Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
06/30/2006
Decision Date
08/01/2006
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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