510(k) K023469

VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062 by Victus, Inc. — Product Code FPA

K023469 is an FDA 510(k) premarket notification submitted by Victus, Inc. for the device "VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062". The FDA issued a decision of Substantially Equivalent on December 10, 2002. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Victus, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2002
Date Received
October 16, 2002
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