510(k) K895480

BLUNT NEEDLE PORT/I.V. PORT by Applied Medical Technologies — Product Code FPA

K895480 is an FDA 510(k) premarket notification submitted by Applied Medical Technologies for the device "BLUNT NEEDLE PORT/I.V. PORT". The FDA issued a decision of Substantially Equivalent on December 1, 1989. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Applied Medical Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1989
Date Received
September 11, 1989
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