510(k) K132880

MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE by Medical Components, Inc. — Product Code FPA

K132880 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE". The FDA issued a decision of Substantially Equivalent on January 8, 2014. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Medical Components, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2014
Date Received
September 13, 2013
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