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510(k) K993463

INTRAVASCULAR ADMINISTRATION SET by Custom Assemblies, Inc. — Product Code FPA

K993463 is an FDA 510(k) premarket notification submitted by Custom Assemblies, Inc. for the device "INTRAVASCULAR ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on January 4, 2000. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2000
Date Received
October 13, 1999
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

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FDA data resources