510(k) K984059

ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code FOZ

K984059 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER". The FDA issued a decision of Substantially Equivalent on April 9, 1999. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1999
Date Received
November 13, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type