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FDA 510(k) Application Details - K053268
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K053268
Device Name
Wire, Guide, Catheter
Applicant
BOSTON SCIENTIFIC - PRECISION VASCULAR
2405 WEST ORTON CIR.
WEST VALLEY CITY, UT 84119 US
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Contact
RICK GAYKOWSKI
Other 510(k) Applications for this Contact
Regulation Number
870.1330
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Classification Product Code
DQX
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More FDA Info for this Product Code
Date Received
11/23/2005
Decision Date
03/13/2006
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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