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FDA 510(k) Application Details - K163000
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K163000
Device Name
Catheter, Percutaneous
Applicant
AGA Medical Corporation (Wholly Owned by St. Jude Medical Co
5050 Nathan Lane
Plymouth, MN 55442 US
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Contact
Mary Johnson
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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
10/28/2016
Decision Date
12/23/2016
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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