510(k) K073210

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

K073210 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "MODIFICATION TO: T-PORT HP INFUSION PORT". The FDA issued a decision of Substantially Equivalent on December 12, 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
December 12, 2007
Date Received
November 14, 2007
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