510(k) K071993

T-PORT HP INFUSION PORT by Pfm Medical, Inc. — Product Code LJT

K071993 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "T-PORT HP INFUSION PORT". The FDA issued a decision of Substantially Equivalent on October 17, 2007. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Pfm Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2007
Date Received
July 20, 2007
Clearance Type
Traditional
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