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FDA 510(k) Application Details - K043401
Device Classification Name
Stylet, Catheter
More FDA Info for this Device
510(K) Number
K043401
Device Name
Stylet, Catheter
Applicant
SPECTRANETICS CORP.
96 TALAMINE CT.
COLORADO SPRINGS, CO 80907-5159 US
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Contact
MICHAEL J RYAN
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Regulation Number
870.1380
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Classification Product Code
DRB
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More FDA Info for this Product Code
Date Received
12/10/2004
Decision Date
03/16/2005
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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