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FDA 510(k) Application Details - K001616
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device
510(K) Number
K001616
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
ABBOTT LABORATORIES
DEPT. 389, AP30
200 ABBOTT PARK RD.
ABBOTT PARK, IL 60064-3537 US
Other 510(k) Applications for this Company
Contact
CHRISTINE L LIONHOOD
Other 510(k) Applications for this Contact
Regulation Number
880.5200
More FDA Info for this Regulation Number
Classification Product Code
FOZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/25/2000
Decision Date
07/27/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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