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FDA 510(k) Application Details - K190855
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
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510(K) Number
K190855
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
Bard Access Systems, Inc. (Bard has joined BD)
605 North 5600 West
Salt Lake City, UT 84116 US
Other 510(k) Applications for this Company
Contact
Sean J. Loring
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
04/02/2019
Decision Date
11/01/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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