510(k) K103562

CENTURION PRESSURE INJECTABLE EXTENSION SET by Centurion Medical Products Corporation — Product Code FPA

K103562 is an FDA 510(k) premarket notification submitted by Centurion Medical Products Corporation for the device "CENTURION PRESSURE INJECTABLE EXTENSION SET". The FDA issued a decision of Substantially Equivalent on June 23, 2011. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Centurion Medical Products Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2011
Date Received
December 6, 2010
Clearance Type
Abbreviated
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