510(k) K050906

VITALCARE I.V. ADMINISTRATION SET by Vitalcare Group, Inc. — Product Code FPA

K050906 is an FDA 510(k) premarket notification submitted by Vitalcare Group, Inc. for the device "VITALCARE I.V. ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on Aug 23, 2005. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Vitalcare Group, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 23, 2005
Date Received
Apr 11, 2005
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