510(k) K030246

VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072 by Victus, Inc. — Product Code FPA

K030246 is an FDA 510(k) premarket notification submitted by Victus, Inc. for the device "VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072". The FDA issued a decision of Substantially Equivalent on February 26, 2003. 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
February 26, 2003
Date Received
January 24, 2003
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