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FDA 510(k) Application Details - K143588
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K143588
Device Name
Catheter, Intravascular, Diagnostic
Applicant
SUREFIRE MEDICAL, INC
6272 W. 91st Avenue
Westminster, CO 80031 US
Other 510(k) Applications for this Company
Contact
Lynne Aronson
Other 510(k) Applications for this Contact
Regulation Number
870.1200
More FDA Info for this Regulation Number
Classification Product Code
DQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/2014
Decision Date
01/12/2015
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
Y
Expedited Review
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