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FDA 510(k) Application Details - K993966
Device Classification Name
System, Balloon, Intra-Aortic And Control
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510(K) Number
K993966
Device Name
System, Balloon, Intra-Aortic And Control
Applicant
ARROW INTL., INC.
9 PLYMOUTH ST.
EVERETT, MA 02149 US
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Contact
WILLIAM PAQUIN
Other 510(k) Applications for this Contact
Regulation Number
870.3535
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Classification Product Code
DSP
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More FDA Info for this Product Code
Date Received
11/23/1999
Decision Date
02/18/2000
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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