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FDA 510(k) Application Details - K030617
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K030617
Device Name
Wire, Guide, Catheter
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311 US
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Contact
ANNE V ROSSI
Other 510(k) Applications for this Contact
Regulation Number
870.1330
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Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/26/2003
Decision Date
05/21/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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