FDA 510(k) Application Details - K953805

Device Classification Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

  More FDA Info for this Device
510(K) Number K953805
Device Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant ABBOTT LABORATORIES
DEPT. 389, AP30
ABBOTT PARK, IL 60064-3537 US
Other 510(k) Applications for this Company
Contact THOMAS F WILLER
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 08/08/1995
Decision Date 06/28/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact