510(k) K112713

NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS by Norfolk Medical Products, Inc. — Product Code LJT

K112713 is an FDA 510(k) premarket notification submitted by Norfolk Medical Products, Inc. for the device "NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS". The FDA issued a decision of Substantially Equivalent on October 27, 2011. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Norfolk Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2011
Date Received
September 19, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type