510(k) K952160

INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) by Medex, Inc. — Product Code FPA

K952160 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)". The FDA issued a decision of Substantially Equivalent on September 21, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Medex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1995
Date Received
May 8, 1995
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