510(k) K842143

BENT WINGED MINI-VOL INFUSION SET by Med Fusion Systems, Inc. — Product Code FPA

K842143 is an FDA 510(k) premarket notification submitted by Med Fusion Systems, Inc. for the device "BENT WINGED MINI-VOL INFUSION SET". The FDA issued a decision of Substantially Equivalent on July 20, 1984. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Med Fusion Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1984
Date Received
May 30, 1984
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