510(k) K781184

INFUSION SET, VENOTHIN 19 by Venospital, Inc. — Product Code FPA

K781184 is an FDA 510(k) premarket notification submitted by Venospital, Inc. for the device "INFUSION SET, VENOTHIN 19". The FDA issued a decision of Substantially Equivalent on August 10, 1978. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Venospital, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1978
Date Received
July 14, 1978
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