510(k) K140133

INFUSET FLOW CONTROL EXTENSION SET by Emed Technologies Corporation — Product Code FPA

K140133 is an FDA 510(k) premarket notification submitted by Emed Technologies Corporation for the device "INFUSET FLOW CONTROL EXTENSION SET". The FDA issued a decision of Substantially Equivalent on May 15, 2014. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Emed Technologies Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2014
Date Received
January 17, 2014
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