510(k) K964050

FIRST MIDCATH CATHETER by Becton Dickinson Vascular Access, Inc. — Product Code FOZ

K964050 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vascular Access, Inc. for the device "FIRST MIDCATH CATHETER". The FDA issued a decision of Substantially Equivalent on January 6, 1997. 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. Becton Dickinson Vascular Access, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1997
Date Received
October 9, 1996
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