510(k) K926119

EXEL HUBER INFUSION SET ROTATING WING by Exel Intl. — Product Code FPA

K926119 is an FDA 510(k) premarket notification submitted by Exel Intl. for the device "EXEL HUBER INFUSION SET ROTATING WING". The FDA issued a decision of Substantially Equivalent on August 11, 1993. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Exel Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1993
Date Received
December 3, 1992
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