510(k) K950302

E-Z SET(R) AND MINICATH(R) INFUSION SETS by Becton Dickinson Vascular Access, Inc. — Product Code FPA

K950302 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vascular Access, Inc. for the device "E-Z SET(R) AND MINICATH(R) INFUSION SETS". The FDA issued a decision of Substantially Equivalent on March 13, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Becton Dickinson Vascular Access, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1995
Date Received
January 25, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type