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FDA 510(k) Application Details - K024126
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K024126
Device Name
Catheter, Intravascular, Diagnostic
Applicant
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
D-389, BLDG J-45
ABBOTT PARK, IL 60064-3500 US
Other 510(k) Applications for this Company
Contact
NICOHL R WILDING
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
12/16/2002
Decision Date
01/14/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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