510(k) K943591

VECTOR(TM) AMBULATORY DRUG DELIVERY SYSTEM by Infusion Technology Intl. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1995
Date Received
July 25, 1994
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