510(k) K081156

CADD MEDICATION CASSETTE RESERVOIR by Smiths Medical MD, Inc. — Product Code FPA

K081156 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "CADD MEDICATION CASSETTE RESERVOIR". The FDA issued a decision of Substantially Equivalent on July 18, 2008. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Smiths Medical MD, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2008
Date Received
April 23, 2008
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