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FDA 510(k) Application Details - K984482
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K984482
Device Name
Catheter, Percutaneous
Applicant
ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC.
129 CONCORD RD.
P.O. BOX 566
BILLERICA, MA 01821 US
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Contact
NORMA J LEMAY
Other 510(k) Applications for this Contact
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
12/16/1998
Decision Date
07/30/1999
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
N
Expedited Review
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